Summary of MedSun Reports Describing Adverse Events With Anesthesia or Analgesia Gas Machines
MedSun: Newsletter #56, January 2011

"A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (Code of Federal Regulations, 2010)."

Over the past 2 years, MedSun has received 41 adverse event reports associated with Anesthesia or Analgesia gas machines manufactured by Draeger Medical GmbH; GE Healthcare, a division of General Electric Company; Mindray DS USA, Inc; and Spacelabs Healthcare, LTD. The reports were submitted by 26 hospitals between November 2008 and November 2010.

The four most commonly reported problems were :
• Device displays error messages (11 reports)
• Device inoperable (10 reports)
• Sensor Issue (6 reports)
• No display or display failure (5 reports)

The following were the patient outcomes for the remainder of the reports:
• Manual ventilation required (5 reports)
• Breathing difficulties (1 report)
• Cyanosis (1 report)
• Insufficient, light or patch anesthesia (1 report)
• Low oxygen saturation (1 report)
• Prolonged surgery (1 report)
• No consequence or impact to patient (14 reports)

Of the reports that listed patient age, three had a patient age listed as less than 21 years and twenty-five had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of twelve reports involved female patients and a total of sixteen reports involved male patients.

These MedSun reports, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with Anesthesia or Analgesia gas machines. The Medsun Reported events may, or may not, be involved in the recall(s) listed.

Recall 1: Class 2 Recall Aisys
Date Posted: June 23, 2009
Recall Number: Z-1425-2009
Product: GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
Code Information: Please see link for a complete list of serial numbers affected.
Recalling Firm/Manufacturer: GE Healthcare; 9900 Innovation Drive Mail Stop: RP2138 Wauwatosa, Wisconsin 53226
Consumer Instructions: Contact the recalling firm for information
Reason for Recall: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch.
Action: GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Quantity in Commerce: 3082

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Recall 2: Class 2 Recall Fabius GS
Date Posted: September 23, 2010
Recall Number: Z-2478-2010
Product: Fabius GS Anesthesia Machine,
OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms
Code Information: catalog #8604699
Recalling Firm/Manufacturer: Draeger Medical Systems, Inc. 3135 Quarry Rd Telford, Pennsylvania 18969-1042
Consumer Instructions: Contact the recalling firm for information
Reason for Recall: Potential failures to Electri-Cord Manufacturing AC power cord
Action: Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: kathy.benedetto@draeger.com. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).
Quantity in Commerce: up to 1973 products (GS & Tiro)

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Recall 3: Class 2 Recall GE Datex-Ohmeda Aisys Anesthesia System
Date Posted: October 06, 2010
Recall Number: Z-0008-2011
Product: GE Datex-Ohmeda Aisys Anesthesia
System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE,
Finland
Code Information: Please see link for a complete list of serial numbers affected.
Recalling Firm/Manufacturer: GE Healthcare, LLC
3000 N Grandview
Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions: No consumer action necessary
Reason for Recall: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient.
Action: GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
Quantity in Commerce: 3039

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Recall 4: Class 2 Recall Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
Date Posted: August 24, 2010
Recall Number: Z-2263-2010
Product: Philips M1013A IntelliVue G1
Anesthesia Gas Modules with manifolds
Code Information: Serial Number range ARYE-0014 to
ASBC-0013
Recalling Firm/Manufacturer: Philips Healthcare Inc.
3000 Minuteman
Road
Andover, Massachusetts 01810
Reason for Recall: The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.
Action: Philips Healthcare issued an "Urgent Device Correction" letter dated July 14, 2010 with an addendum to the Instructions for Use including additional instructions for the replacement of the water trap for the Philips M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia Gas Modules. This addendum is being sent along with the Urgent Medical Device Correction notice to all affected customers. Customers will be requested to incorporate the information contained in the Urgent Medical Device Correction notice and the Addendum to the Instructions for Use with the existing labeling (Instructions for Use) provided with the product. Customers can contact Philips at 1-800-722-9377 for further information..
Quantity in Commerce: 531 units

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Recall 5: Class 2 Recall BleaseSirius Anaesthesia Machine
Date Posted: July 29, 2010
Recall Number: Z-2113-2010
Product: leaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room.
Code Information: Serial numbers:
DOMESTIC - SIRI-001818, SIRI-001819, SIRI-001821, to SIRI-001829, SIRI-001851, SIRI-001852, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-002106, SIRI-002108, and SIRI-002292.
INTERNATIONAL - SIRI-2302, SIRI-001611, SIRI-001612, SIRI-001614 to SIRI-001617, SIRI-001785, SIRI-001786, SIRI-001846 to SIRI-001850, SIRI-001853, to SIRI-001855, SIRI-001857, SIRI-001858, SIRI-001861, SIRI-001862, SIRI-001911, SIRI-001903 to SIRI-001905, SIRI-001921, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001954, SIRI-001961, SIRI-001963, SIRI-001964, SIRI-002041, SIRI-002135, SIRI-002139, SIRI-002150, SIRI-002156, SIRI-002157, SIRI-002159, SIRI-002162, SIRI-002166, SIRI-002168, SIRI-002169, SIRI-002171, SIRI-002201, SIRI-002224. SIRI-002298, SIRI-002304, SIRI-002315,SIRI-002349, SIRI-002354, and SIRI-002363.
Recalling Firm/Manufacturer: Spacelabs Healthcare, Llc 5150 220th Ave Se Issaquah, Washington 98029-6834
Reason for Recall: Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.
Action: On 06/24/2010, Spacelabs began mailing the URGENT-MEDICAL DEVICE CORRECTION letter to their US consignees and e-mailed the same letter to their foreign consignees. The letter describes the touch screen of the BleaseSirius Anesthesia machine goes blank when touched and the possibility that this failure may cause the mechanical ventilation to stop. The consignees are asked to weigh the benefits versus the risk when deciding to use the device or not until the firm upgrades the device. The letter also instructs the consignees to notify their staff about the possibility of the display failure to prevent any adverse event that may occur. The letter states that their field service engineer will contact consignees to schedule a time to visit and upgrade all affected devices at no cost. The US consignees are advised to call 1-800-522-7025, Select 2, and the foreign consignees are advised to call 1-425-657-7200 x5089 for technical support or questions regarding the recall.
Quantity in Commerce: 80 units total

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Recall 6: Class 2 Recall Anesthesia system
Date Posted: April 16, 2010
Recall Number: Z-1408-2010
Product: The BleaseSirius and BleaseFocus
Anaesthesia Systems.
Code Information: Serial numbers:
Siri 000116, Siri 000885, Siri 001100, Siri 001609, Siri 001610, Siri-001618, Siri-001626, Siri-001637, Siri-001640, Siri-001644, Siri-001658, Siri-001666, Siri-001667, Siri-001668, Siri-001674, and Siri-001681. Focu-000735, Focu-000737 to Focu-000751, Focu-100001, Focu-100003 to Focu-100009.
Recalling Firm/Manufacturer: Blease Medical Equipment, Ltd.Deansway, Chesham Bucks, England
Reason for Recall: Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
Action: On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010. The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives. For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089. Non US Customers, call Global Technical Support - +44 1494 784422.
Quantity in Commerce: 40 units

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Recall 7: Class 2 Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Date Posted: April 08, 2010
Recall Number: Z-1313-2010
Product: Datascope AS3000 Anesthesia System;
Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
Code Information: Product numbers 0998-00-3024-01.
Recalling Firm/Manufacturer: Mindray DS USA, Inc., dba Datascope Patient
Monitoring800 Macarthur BlvdMahwah, New Jersey 07430
Reason for Recall: An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
Action: An "URGENT PRODUCT FIELD CORRECTIVE ACTION" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost. If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or k.maine@mindray.com.
Quantity in Commerce: 372 units in US, 107 internationally.

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Recall 8: Class 1 Recall GE Aisys
Date Posted: May 11, 2010
Recall Number: Z-1526-2010
Product: GE, 1011-9000-000 Aisys Anesthesia
Machine and Monitor
Code Information: Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830 to ANAN00839, and ANAN00873.
Recalling Firm/Manufacturer: Ge Healthcare, Llc3000 N Grandview BlvdWaukesha, Wisconsin 53188-1615
Reason for Recall: Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Action: Consignees were sent a GE Healthcare" Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in Commerce: 15 (OUS)

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The following table lists the MedSun reports that are described in the device problem summary above. The reports have been edited for clarity.

Adverse Events
ManufacturerProduct Model Number Catalog Number Event Description
Draeger Medical Fabius GS * * Towards the end of a pediatric dental procedure, the anesthesiologist observed a message on the Drager Fabius GS anesthesia machine "flow sensor failure". He unplugged the flow sensor cable and then reconnected it. He called for biomedical engineering. The flow sensor was then glowing red and smoking. The procedure had already been completed and the pt was being moved out of the room. On examination of the sensor after the incident, it was noted that the plastic sensor cartridge was blackened, melted in places and the sensing electrodes inside it were black.
GE Medical AISYS Carestation S5 AISYS NA During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part.
GE Datex-Ohmeda Anesthesia Unit S5 AISYS * During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part. The suspected part was sequestered. This is the second time this event has occurred.
GE Medical S/5 AVANCE AVANCE Carestation * During a cardiac procedure on an infant with an interrupted aortic arch defect, the inspired CO2 reading on the anesthesia machine started rising to the mid 30 mmhg CO2. The patient was under pressure support ventilation on the anesthesia machine's ventilator. The patient's PCO2 was starting to give readings above 100 mmhg and physician was concerned about respiratory acidosis occurring. The physician then exchanged the ventilator to a stand alone vent and was able to get the inspired CO2 to drop in pressure support ventilation on the exchanged ventilator. Physician noted to biomedical that elevated inspired CO2 readings were occurring frequently during pressure support ventilation on all the anesthesia machines while ventilating infant patients and neonates.
GE Medical * * Power switch caused machine to shut down. Had to change out machine in middle of surgery. This has happened in the past and GE related to us that they are having trouble with the power switch failing. GE advised us that when this is going to occur that the machine will give a visible display that it is going to shut down in 8 seconds. Then we should turn the switch to standby. Once the machine shuts down - wait for 10 seconds until compressed air is heard. Then the machine will reboot itself.
GE Medical AISYS Carestation AISYS * In the middle of the case the patient had to be bagged while the anesthesia delivery machine was changed out. The switchout involves a change in circuits and a pedi-lite sensor. Anesthesiology was not aware that an upgrade for the carestation anesthesia delivery system was needed to take care of smaller children. We bought our machines at different times. The first ones were sent with the upgrade by mistake. The next order was not.
GE Medical S5 AISYS S5 AISYS NA "Vaporizor failure" shows on screen. No longer shows a vaporization concentration on screen. Surgeon gives estimate of 5-10 minutes to end. Switch to IV propofol for anesthesia to finish case and reduce fresh gas flow to minimize wash-out of sevoflurane. Extubate patient at end and take him to PACU breathing well, awakening.
GE Medical AISYS * * Anesthesia machine gave notice of impending shutdown in 8 seconds, while case was underway. It shut down and indicated to cycle the power switch. The machine came back on but no information was coming from gas analyzer. Display indicated device zeroing and warming, but did not achieve zero. Clinical engineering replaced gas analyzer at that time and replaced entire anesthesia machine at end of case. At the time of this entry a GE technician has evaluated the machine and replaced the suspected defect, a power switch.
GE Medical AISYS Carestation * * Could not properly ventilate a patient that was under general anesthesia for a procedure. The ventilator could not deliver the set tidal volume. Set tidal volume was ~ 700ml and unit was showing delivering ~ 100ml. It appeared that the flow sensors were not measuring inspiratory/expiratory volumes, or that there was a major leak that was missed. The following alarm messages appeared on the ventilator screen: "reverse exp flow. Check valves OK?" and "system leak?" Biomed was called for help. Machine was checked for leaks, but nothing was found. While the patient was ventilated with an ambu bag, the flow sensors were replaced without improvement. The condenser was checked and was emptied. It contained a lot of water. The machine was shut down and rebooted and the problem persisted. Finally the flow sensor module was disconnected and reconnected for a second time and the problem disappeared. However, this flow sensor issue has been happening for at least several months, multiple times with several Aisys machines at our facility. Usually the tidal volume readings are in accurate and flow sensors are swapped out intraoperatively or if unable to resolve the issue, the entire machine is swapped out.
GE Medical AISYS Carestation S5 AISYS * During a scheduled preventive maintenance inspection, it was noticed that there was rust on the rod of the bag/vent switch assembly. The assembly was replaced with a new part. The suspected part was sequestered.
Draeger Medical Fabius GS Fabius GS * Found a trend where the clip adapter is coming loose on the soda lime canisters. In both cases found soda lime canister not connected properly and clip adapter loose on the floor.
GE Medical Datex-Ohmeda S/5 * * Gas monitoring problems detected. On the display showing gas information, the displayed numbers went blank intermittently. No patient harm. Biomedical engineering contacted and worked with manufacturer to perform a factory reset. The reset involved clearing the anesthesia unit's memory, then reloading all the default information and checking for proper operation. The reset did not correct the problem, as it recurred as an intermittent problem thirteen days later. At that time, the factory service technician, working with our biomed department, replaced the display and the circuit board which feeds the gas information to the display. The problem has not returned since.
GE Medical AISYS * * Patient was status-post aortic root hemi-arch repair and had a mediastinal hematoma. Patient was brought to the or for re-exploration and evacuation of hematoma and repair of annular bleeding. Prior to the surgery the patient may have had hypoxic ischemic encephalopathy. During the preparation for the surgery it was noted that the patient was turning cyanotic and there was no saturation monitoring pick-up. The tidal volume on the anesthesia machine was set for 800cc but when the patient became cyanotic it was noted that the bellows were not pushing 800cc. The patient was taken off the anesthesia machine and was hand bagged with 100% oxygen until he recovered. He was placed back on the anesthesia machine and there were no further issues. During resuscitation the surgeon performed open cardiac massage.
GE Medical AISYS * * Patient under anesthesia in or for redo of coronary artery bypass x3. Prior to start of surgery it was noted that the ventilator on the anesthesia machine set to deliver 850cc of tidal volume but bellows would only push 400cc. Tubings changed, flow sensors changed but did not resolve problem. Pt was hand bagged while anesthesia machine was changed out. Surgery delayed but no patient injury.
GE Medical AISYS * * Patient in OR for thoracotomy. During the surgery it was noted that the anesthesia machine ventilator was set to deliver 450cc of tidal volume, bellows appeared to be delivering such but return volume was only reading 50-300cc. Flow sensors were changed numerous times but continued to be a problem. Patient blood gases were monitored during the procedure and appeared to be within normal limits so machine was not changed out. There was no patient harm.
GE Medical Datex-Ohmeda ADU * * System error on machine during turnover of operating room between 1 case and the next one. No patient involved. "Unexpected reset"
GE Medical Datex-Ohmeda S/5 ADU * * Between operating room cases an "unexpected reset-system failure" occurred.
GE Datex-Ohmeda Datex-Ohmeda ADU Carestation ADU * Just after patient was intubated, anesthesia machine shut down and was not working. A new machine was brought into the room and exchanged while the patient was ventilated from an oxygen tank.
GE Medical AISYS AISYS * In middle of the anesthetic, the Aisys machine displayed the warning "Calibrate flow sensors". To perform this calibration, the flow sensor assembly needs to be withdrawn from the machine and reinserted, and I did this. While performing this task the flow sensor connectors became disconnected. I could not replace the flow sensor connectors - both the need to reinsert the connectors into a holding device and the correct position up/down within the holding device were unclear. Therefore we were left with a non-functioning anesthesia machine in the middle of the anesthetic. In order to preserve the patient's safety, we got the emergency bag-valve-mask device and began to deliver ventilation. Biomed engineers were called. Emergency ventilation was performed. To avoid patient awareness and pain, anesthesia was replaced with propofol, since the sevoflurane anesthesia was being removed by the manual resuscitator that can deliver only oxygen. Sevoflurane anesthesia was reinstituted once the anesthesia machine was put back together and was functional again. Emergency actions were successful and patient safety was maintained. She had no vital signs perturbation or desaturation, and afterwards reported no intraoperative awareness.
Draeger Medical * * * During case, anesthesia machine faulted with a # 9 code. Dr looked at manual, and started to run through settings to repair the fault # 9. The machine shut down. Patient hand bagged throughout the rest of case. Drager medical called and reported. Mfr's rep will be in today to look at problem. Patient was transported to PACU after the surgery was completed with a oxygen saturation of 86-89%. The patient was discharged from PACU in stable condition with spontaneous respirations and oxygen saturation of 100%.
GE Datex-Ohmeda AESTIVA 3000 AESTIVA 3000 UNKNOWN While patient was undergoing hernia repair, anesthesia machine failed. Patient was ventilated manually for a few breaths and then allowed to breath spontaneously for the remainder of the case. No adverse impact on patient.
GE Datex-Ohmeda * * * Flow sensor failed, giving alert message "replace flow sensor" replacement sensor also failed. Multiple sensors from the same lot number have the same problem. This resulted in significant disruption of the surgical procedure and required hand ventilating the patient for about 10 minutes while the various components of the machine were exchanged.
GE Medical Anesthesia Machine AISYS * APL (adjustable pressure limiting) valve came loose from anesthesia machine while being adjusted.
GE Medical Datex-Ohmeda ADU * Patient was asleep in the or during a surgical procedure. Hospital experienced power surge due to a transformer blowing outside of OR. Patient began moving around. Discovered anesthesia gas administration disrupted. Patient's safety protected. Anesthesiologist put patient back to sleep. Patient has no recollection of event.
Draeger Medical NARKOMED 2B * * Surgical procedure being performed. Anesthesia machine set to deliver 12% desflurane and according to the monitor the patient was only receiving 6% and was showing signs of waking. Machine did not alarm.
Draeger Medical Apollo * * O2, N2O and AGT (agent) reading disappeared from display, and would intermittently return. Replaced and tested PATO sensor head, unit returned to service.
Draeger Medical Apollo Apollo * Anesthesia machine was found waiting for inspection/repair with a user's note attached that implied an O2 sensor problem. Initial testing by biomed technician identified a failure of gas analyzer and O2 sensor. Replacement part (PGM assembly) was ordered. Later the same day, technician repeated the test and all results were ok. Technician then set machine to monitor 100% oxygen (machine's O2 sensor indicated 97%) for 22 hours. When checked at end of test, machine's O2 trend showed a brief drop to 78% at one point, then recovery to 100%. PGM assembly was replaced as a precautionary measure. All subsequent tests passed, and machine was returned to use.
GE Medical AISYS * * An anesthesia machine in the operating room (OR) had a leak in the carbon dioxide absorbent connection. The rubber ring fell out of place.
Draeger Medical Apollo Apollo * An upgrade of our Compurecord patient charting program from version D.02 to F.00 was necessary to allow operation with Baytech's new model DS3 acquisition unit. (our existing M4 and M8 models are no longer available.) After the upgrade was completed, users reported that a "Comm port 1 fail" error message was occurring periodically on the anesthesia machine. It was determined that on Apollo anesthesia machines using the M4 or M8 units, the "Comm port 1 fail" message was displayed briefly at ten second intervals, although the actual patient data acquisition and recording seemed unaffected. For Apollo machines using the DS3 unit, there is no error message, but the acquired patient data in the Compurecord chart appears for 15 seconds and disappears for 30 seconds, producing periodic gaps in the patient's saved data record.
GE Medical S/5 AVANCE Carestation S/5 AVANCE Carestation * While transporting an anesthesia machine back to surgery, the right rear caster threaded stem snapped and the machine tipped to the floor, causing extensive damage to machine and accessories. Staff was not injured in this event. Staff noted that machine was rolling smoothly prior to wheel separation.
Spacelabs BleaseSirius BleaseSirius * I am writing to report an anesthesia machine malfunction that occurred in the OR this month. This case involved a small infant. The dialed tidal volume was 60 ml and the machine was registering 100ml, 120 ml and at one point over 2000 ml. There was a problem with the ETCO2 reading, too, with readings ranging from 40 to 100. There was also CO2 rebreathing. The sodalime cannister was changed out when the inspired CO2 was reading 6. It seemed to resolve the problem initially but then started giving readings of up to 19 with the ETCO2 showing 73-77.
GE Medical Datex-Ohmeda AS/3 ADU * ETT was hooked to anesthesia machine. Patient was induced. After 5 minutes of normal function, the machine suddenly gave a message stating "unexpected re-set, call for service." machine continued operating under existing settings, but now you cannot see or adjust the ventilator settings. Screen is stating message instead of vent settings etc. Other parts of anesthesia machine were working: cardiac monitoring; blood pressure; end-tidal CO2; and expired anesthesia gas levels. Able to continue the case without using the ventilator settings. Anesthesiologist obtained loaner from GI lab as standby. Case was able to be completed successfully. Patient extubated. Machine re-programmed itself after the procedure when reset by anesthesiologist. Problem did not recur. Anesthesiologist was unable to reproduce the failure after the procedure.
GE Medical Aestiva 5 * In the morning, the biomed responded to a problem in the OR. Aestiva ventilator stopped. Dr. was manually bagging patient. Aestiva ventilator had a warning message, prompting user to push knob to acknowledge vent had experienced a problem. Doing this cleared the message and allowed the user to return to ventilator mode, however, the problem reappeared after a few minutes.
GE Medical Aestiva * * Elderly female patient taken to or for total knee procedure. It was reported by the anesthesia tech that the Datex Ohmeda Aestiva-5 anesthesia machine had encountered problems. It was noted the bellows on the machine were not rising appropriately. Back up machine was obtained and switched out with original machine with no further reported issues with either the 2nd machine or the patient. Anesthesia tech reports upon troubleshooting the issue it was noted the machine had an excessive amount of dust originating from the CO2 absorbent canister. We have reported this problem with this product previously but this is the first time it has directly affected patient/procedure. Our hospital had determined we would not be using this product as soon as the replacement product we had found (Amsorb plus) arrived at our hospital. Our facility has now just learned the supplier of Sodasorb has now determined they will not be ordering from this particular vendor anymore and will be returning to their original product (Medisorb) which had been discontinued. No injury to patient, just a delay in procedure with having to switch to an alternate machine and an impact of time as it took our anesthesia staff time to clean large amount of dust out of machine and run machine through its paces before feeling secure enough to return it to service.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * There was no patient harm. The MD was unable to turn on the ventilator. The ventilator screen turned off. Pt had to be manually ventilated.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * No pt harm. The ventilator screen darkened and the vent turned off. The pt was manually ventilated.
Mindray DS USA AS3000 Anesthesia Delivery System AS3000 * Ventilator panel of anesthesia machine went blank and was inoperable.
MINDRAY DS USA AS3000 Anesthesia Delivery System AS3000 * Bellow of the anesthesia machine was not arising to the top even though tidal volume was delivered.
GE Datex-Ohmeda ADU Carestation S/5 * Anesthesia delivery unit stopped ventilating patient, CRNA certified registered nurse anethesthetist and SRNA student registered nurse anesthetist had to hand ventilate until new machine could be brought into room. CRNA board runner located another machine and brought into room. Patient remained hemodynamically stable and amnestic throughout the change in anesthesia machine. Ventilator thought to have failed while changing between pressure control ventilation and volume control. Biomed reviewed error codes on machine. Contacted manufacturer and determined that the inspirational proportional valve needs to be replaced. Will repair and return to service.
GE Datex-Ohmeda ADU Carestation * * The anesthesia machine system check-out procedure was passed in am prior to start of the day's cases. During the first case, the ventilator turned on, but the CRNA certified registered nurse anesthetist noticed that bellows were not cycling. The case proceeded with manual ventilation and the machine was changed-out after the case. The patient suffered no adverse effects.
GE Datex-Ohmeda AISYS Carestation * * During a procedure, the anesthesia machine stopped working and gave a message "try another cassette, schedule service." this has occurred before with no problems found in the logs or VAP test. Machine passed all checks. The machine was turned off, then on again to clear and began working for the remainder of the case. The machine was changed out of the OR suite and replaced. There was no injury to the patients.

Additional Information:

Recall 1: Class 2 Recall Aisys. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79156.

Recall 2: Class 2 Recall Fabius GS. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94224.

Recall 3 : Class 2 Recall GE Datex-Ohmeda Aisys Anesthesia System. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94054.

Recall 4: Class 2 Recall Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93109.

Recall 5: Class 2 Recall BleaseSirius Anaesthesia Machine. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92556.

Recall 6: Class 2 Recall Anesthesia system. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90223.

Recall 7: Class 2 Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89325.

Recall 8: Class 1 Recall GE Aisys. Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90650.


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