Highlighted Reports
MedSun: Newsletter #51, August 2010

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period May 1 through May 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device 1:
Type: Anesthesia Machine
Manufacturer: Draeger Medical Systems, Inc.
Brand: Apollo
Model: Apollo
Other #: software version 3.21

Device 2:
Type: Anesthesia Recordkeeping System
Manufacturer: Philips Medical Systems North America, Inc.
Brand: Compurecord
Other #: software version F.00

Problem:
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.
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Health Professional's Impression
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Recurring Comm Port Fail alarms are a distraction for the anesthesiologist and may cause genuine alarm messages to be overlooked. Frequent gaps in the patient's data record are not acceptable.
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Manufacturer response for Anesthesia Machine, Apollo
======================
Drager tech support affirmed that all source code for their Medibus protocol is provided to vendors. There are two software versions current in Apollo machines; ver 3.21 and ver 4.10. It's possible that CompuRecord software may be qualified to one version and not the other.
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Manufacturer response for Patient Charting program, CompuRecord
======================
Initial reply was that CompuRecord periodically polls the comm port looking for information, and that the "Comm Port 1 Fail" message was "normal" for version F.00. There was no comment about repeated 30-sec periods of lost patient data. After additional communication, Philips is investigating compatibility of version F.00 with both Drager software versions and the BayTech DS3 unit.
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Manufacturer response for digital acquisition unit, BayTech
======================
Mfr provided information that obsolete models M4 and M8 contained internal digital memory. Newer model DS3 is a digital switch only and contains no internal memory.


Device:
Type: Catheter, Epidural
Manufacturer: Arrow International, Inc. (subsidiary of Teleflex, Inc.)
Brand: Flextip Plus
Lot #: RF 8123601
Other #: 122208 1813

Problem:
Doctor placed CLE (continuous lumbar epidural) catheter without incident. When he attempted to push his medications through the catheter, it was completely occluded. MD tried to troubleshoot but realized it was a catheter malfunction. Catheter had to be removed and patient had to be stuck again due to faulty equipment.
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Health Professional's Impression
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Doesn't know


Device:
Type: Connector, Airway Access
Manufacturer: Carefusion 211, INC.
Brand: Neo-verso
Cat #: CSC200

Problem:
Nurse called to infant's bedside because he had been desaturating. Patient currently being hand bagged. When we tried to reattach infant to ventilator patient started to desaturate again. Tried to suction patient at this time but unable to pass in-line suction catheter through airway access adapter. Trach tube appeared to be obstructed. The infant returned to baseline after a new trach tube was placed.
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Health Professional's Impression
======================
The airway access adapter is really a Y-connector that allows staff to suction the airway without disconnecting the ventilator. Apparently a silicone seal came off the adapter and lodged in the cone-shaped input of the trach tube causing the obstruction.
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Manufacturer response for Airway Access Adapter, AirLife
======================
No official comment yet.


Device:
Type: Flowmeter, Tube, Thorpe, Back-pressure Compensated
Manufacturer: Precision Medical
Brand: Select Flowmeter
Model: Ohmeda
Cat #: 3MFA1005

Problem:
Flowmeter had a crack in its base which was not easily visible, but a modest weight (e.g., humidifier) attached was enough to spread the crack and cause leakage. The flowmeter indicated proper flow, but very little of it entered the humidifier to the patient. When the problem was discovered and the flowmeter was replaced, the result was "noticeable improvement" in the patient's O2 saturation.
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Health Professional's Impression
======================
Physical damage was already visible on the flowmeter when it was put in use. Most of one hose barb and a 2-cm portion of the base were broken off. Attempted use of the obviously damaged flowmeter led to the problem of the leaking crack and inadequate oxygenation of the patient, which may have been avoided if the flowmeter had been reported and sent for testing after it was damaged.
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Manufacturer response for Oxygen flowmeter, Select
======================
Manufacturer was given details and photographs, and did not think it was necessary to have flowmeter sent to them.

See device images:
Image of flowmeter with cracked base.  Resulted in inadequate patient oxygenation.

Image of flowmeter with cracked base. This shows the flowmeter and tubing. Resulted in inadequate patient oxygenation.

Device:
Type: Laryngoscope, Video
Manufacturer: Verathon Medical
Brand: Glidescope Gvl
Model: Ranger

Problem:
Patient presented to ED [Emergency Department] with c/o [complaints of] aphasia and right sided facial droop. Patient examined and believed to be experiencing a stroke. Plan made to transfer patient to higher level of care for specialty treatment for stroke. Patient was requiring intubation. MedEvac [Medical Evacuation] flight team member was attempting to intubate patient using the GlideScope Ranger when the screen became difficult to view. It appeared to lose video feed and had black lines through the screen. The MedEvac staff member adjusted the screen, moved the handle and checked the cord. The MedEvac staff member was unable to duplicate the circumstances initially but then had a sudden clear view moments later. However, the screen then went back to incomplete views and at times had a total black screen. MedEvac staff member stated that he was removing the handle when the screen became viewable again, so intubation was quickly achieved at this time. No further issues with patient. No injury noted. Possible small delay with intubation but no decline in patient's respiratory status during this incident. Patient's transfer was then continued to other facility. Manager of MedEvac was contacted and he took scope to Clinical Engineering for analysis/interrogation.


Device 1:
Type: Tube, Tracheostomy
Manufacturer: Covidien Shiley
Brand: Shiley 4cfs Cuffless
Model#: 582060
Other #: Shiley 4 CFS

Device 2:
Type: Tube, Tracheostomy
Manufacturer: Smiths Medical
Problem:
An order was placed [within the hospital] for a tracheostomy tube size 5. A Shiley size 4 trach [was ordered] based on the manufacturer's guidelines that a Smiths Medical size 5 is the same as a Covidien Shiley size 4. So, when you go to give the clinician a size 5 trach, you have to get a Covidien Shiley size 4. So the size 5 trach for Covidien Shiley will have a 4 on the box since the sizes are not equivalent. It is very confusing for the doctors and respiratory therapists since the sizes are not comparable amongst different vendors. It is a process that is set up for confusion and error.
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Health Professional's Impression
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The labeling and packaging for the sizes is not consistent amongst Smiths Medical and Covidien Shiley for Tracheostomy Tubes.


Device:
Type: Ventilator
Manufacturer: Covidien Puritan Bennett
Brand: 840
Model#: 840

Problem:
Ventilator failed during operation, went inoperative and alarmed. This problem occurred in 4 different ventilators with a total of 6 BDU replacements. The time between initial purchase and failures is as follows:

Vent 1 11 months
Vent 2 27 months (Subsequent failure: 4 months)
Vent 3 26 months (Subsequent failure: 4 months)
Vent 4 15 months
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Manufacturer response for Ventilator, 840
======================
Manufacturer service engineer responded and replaced BDU CPU [breath delivery unit central processing unit]and Exhalation Valve. The manufacturer has provided no communication as to the root cause.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Bio-Med Devices
Brand: Crossvent
Model#: 2i

Problem:
Transport vent turned on for set-up prior to placing patient in isolette. Touch screen control turned on but did not respond to touch and therefore ventilator could not be used for transport. Patient required manually ventilation for transport.
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Health Professional's Impression
======================
Touch screen was broken.
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Manufacturer response for ventilator, Crossvent 2i
======================
Sent for repair. Touch screen replaced.


CARDIOVASCULAR

Device:
Type: Catheter, Ablation, Cardiac, Ep
Manufacturer: St. Jude Medical
Brand: Therapy Cool Path
Lot #: K21374
Cat #: IBI-83327

Problem:
The catheter tip was bent before it was used. It was an out-of-package failure.


Device:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Lot #: 15082675
Cat #: NI75TCFH

Problem:
After the procedure was underway, the mapping catheter kept jumping around on the screen even though they were not moving the catheter and the patient was not moving either. Unable to acquire mapping points accurately. The ablation catheter was replaced with a new one and problem was resolved. No harm came to this patient.


Device:
Type: Defibrillator, Implantable
Manufacturer: Medtronic, Inc.
Brand: Secura Dr
Model#: D224DRG

Problem:
The patient was admitted via ED three days ago, with the chief complaint: "defibrillator keeps going off." The patient was in rapid atrial fibrillation at that time, "which necessitated multiple ICD charges and shocks in rapid succession. The charge time exceeded the allowance of the device and the end of service indicator was triggered: recommendation is to perform an ICD generator change/replacement since the ICD will not function properly." The ICD was explanted and another ICD implanted. The device was returned to Medtronic for evaluation. The patient's outcome from the EP perspective was satisfactory.
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Health Professional's Impression
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The physician believes that this was the sentinel event that lead to the Medtronic notice.
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Manufacturer response for ICD, SECURA
======================
"...Medtronic will be informing physicians of a rare device software issue in our current ICD and CRT-D devices. The good news is that this issue can be resolved by a software download installed via the programmer. As of April 19th, 2010, Medtronic has 5 confirmed reports out of approximately 144,000 devices worldwide. No patient injuries or deaths have been reported as a result of this issue. Medtronic has identified the root cause to be associated with a rare and specific sequence of events that must occur within milliseconds of each other. Medtronic estimates that the rate of occurrence of this specific sequence of events resulting in excessive charge times in an ambulatory setting to be 1 in 27,000 devices per year (.0000037 per year). We will be responsible for loading the updated software on your programmers and we anticipate the software will be FDA approved in the next few days. Once the software is loaded, upon a patients' next in-clinic interrogation the device will receive the update and their device will be corrected.


Device 1:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Fidelis
Model#: 6949

Device 2:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Quattro Secure
Model#: 6935

Problem:
The patient was found to have a fractured Right Ventricular (RV) lead during follow up and underwent RV lead extraction and reimplantation of new lead and azygos coil. The new lead was open but not used. It had to be changed because the lead had problems with the screw-in mechanism. No injury was caused to the patient, however Medtronic would like both leads returned to them for analysis and possible credit to the hospital.


Device 1:
Type: Pacemaker, Implantable
Manufacturer: ELA Sorin
Brand: Reply Dr

Device 2:
Type: Pacemaker, Implantable
Manufacturer: ELA Sorin
Brand: Reply Dr

Problem:
A patient with complete heart block was undergoing placement of a dual-chamber pacemaker implant. After the placement of an ELA ventricular lead in the right ventricular apex and an atrial lead, both leads were connected to the ELA Sorin REPLY device which had exhibited intermittent loss of capture in the V lead. Another device was tried and also failed. A Zephyr St. Jude generator was then connected and functioned successfully. There did not appear to be a problem with the leads since the third pacemaker worked. There was no patient harm.


Device:
Type: Physiological Monitor, Module
Manufacturer: Philips Medical Systems
Brand: Intellivue Mms
Model#: M3001A

Problem:
While monitoring the ECG waveform on the MP90 monitor, for no apparent reason the QRS complex flat lines and the monitor alarms asystole. While alarming asystole the waveform will produce what appears to be a square wave (an overload of input to ECG module) and then back to flat line and some time later corrects itself. During one of the early incidents a nurse had a patient on a drip to slow down the heart rate. When she saw asystole alarm she immediately shut down the drip. As she continued to review data on the monitor she realized the alarm and waveform were incorrect and that the arterial blood pressure (ABP) and central venous pressure (CVP) were correctly displaying good pleth waveforms. No adverse outcome, but the monitor caused a response from the nurse that stopped treatment. This problem has occurred in all three ICU's and at random beds at random times and only one monitor at a time. During investigation there were external devices used; a wireless laptop was in use in the bed next to the affected bed. By turning on and off the laptop we could reproduce the problem. A Blackberry phone in the area would repeatedly cause the monitor to alarm Asystole. In a different ICU 8 floors away a ventilator with heated circuit caused asystole alarm.
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Health Professional's Impression
======================
Philips Field Service Engineer queried fellow Field Service Engineers (FSE) and learned our MMS ECG firmware version D.02.02 needed to be upgraded. FSE upgraded all MMS ECG firmware (in MP90 monitors) to D.02.05 and X2 model monitors to release G.01.76. This was done to prevent the possible interference caused by Neptune heaters (humidifiers) in the patient ventilators.

Humidifier research engineers contacted this reporter regarding the incident at this facility and a sister facility. They stated there is an issue with another company's monitors and the Neptune heated circuits and were concerned about Philips Monitors. They informed us that they are in the process of a software upgrade to eliminate potential interference with physiological monitors by raising the frequency used in the heated circuits.
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Manufacturer response for Physiological Monitor, Module, INTELLIVUE MMS
======================
Field Service Engineer upgraded all MMS ECG firmware to release D.02.05 in an attempt to reduce or eliminate the ECG
interference they were experiencing. The issue could be replicated by use of a cellular phone and a laptop computer using a wireless card. After the upgrade, no interference was observed.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Gastroscope, Esophageal, Endoscope, Flexible, Rigid
Manufacturer: Olympus
Brand: Gastroscope
Model#: GIF-Q180

Problem:
A gastroscope was not insuflatting properly while in the patient. The scope was removed from the patient and the physician irrigated the biopsy port. At that point a brown substance was expelled. This scope was sent to biomed for the issue of non-insufflation. Biomed could not duplicate the problem and put the scope and cart back into service. The scope has been reprocessed and sent to the manufacturer for a thorough evaluation, repair and replacement.


GENERAL HOSPITAL

Device:
Type: Ambulatory Infusion Pump
Manufacturer: Smiths Medical, Inc.
Brand: Cadd Solis
Model#: 2100

Problem:
Over the past few months, I've begun to see an increase in the number of downstream occlusion alarms. Clinical Engineering has documented several instances in which the occlusion alarm is occurring at 4-5 psi when the initial test value when purchased 14 months ago was near 18 psi.
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Health Professional's Impression
======================
I believe that the pressure sensor is drifting out of specification over time. Devices sent to the manufacturer have either had the sensor replaced or calibrated. No repaired device has subsequently failed.

Device:
Type: Catheter, Picc
Manufacturer: VYGON
Brand: Vygon Premicath
Model#: 1261.203
Lot #: 041580
Cat #: 1261.203 28G (1Fr)

Problem:
A premature neonate was born by emergency Cesarean and was admitted to the NICU for management of issues related to his prematurity. The next day the neonate underwent the insertion of a peripherally inserted central catheter (PICC) for long term intravenous access using a Vygon Premicath Model 1261.203 1Fr catheter. The PICC was placed without incident and chest x-rays were done to facilitate and confirm placement. The line was subsequently used to deliver intravenous fluids and total peripheral nutrition without complication.

On day seven, during a routine IV tubing change, the nurse disconnected a connector and discovered that a guidewire was still in place within the PICC catheter. The neonatologist was notified and the guidewire was easily removed. The wire appeared to be fully intact. The length of the wire was compared to a second wire from an unused kit and they were identical in length. A chest ex-ray was obtained after the wire was removed and the PICC line remained in good position. The neonate suffered no harm nor was there a change in treatment plan based on this event. The package insert that indicates that the stylet needs to be removed is labeled with a size 6 font with a gray color on an onionskin paper.
The neonatal intensive care unit had recently switched to this brand of 1 Fr PICC line, which has a guidewire in place within the line to provide extra rigidity for easier advancement. The guidewire is attached through a port that closely resembles an access port for intravenous fluids. There are no identifying markings on this port and the guidewire is not visible. There are no labels or inserts indicating the presence of the guidewire. No previous brands or models of 1 Fr PICC lines used by NICU clinicians had contained guidewires including a similar model - Vygon Premicath 1261.20 -- staff was not accustomed to the presence of the guidewire.


Device:
Type: Catheter, Picc, Stylet
Manufacturer: BARD Access Systems, Inc.
Brand: Groshong Nxt Picc
Lot #: REUC0254

Problem:
Patient presented to outpatient department for PICC dressing change and brought to the nurse's attention that a wire appeared to be inside the PICC tubing. The nurse was also able to visualize this wire. This PICC line was removed and replaced with another PICC, Groshong. An x-ray was taken of the patient's chest following removal of the guidewire which confirmed proper placement with no issues identified. The patient was discharged. The PICC in question was xrayed and it was determined that there were two pieces of the guidewire inside the Groshong. The hospital staff then tested a second PICC (#2) from a new package (lot# REUB1198) by running it gently through the fingers upon which the guidewire fractured just above the magnetic rings. A similar issue was discovered involving a different type of PICC kit, which also included the Sherlock guidewire from a different facility in the organization - lot# RETK0645/Power Picc with Solo catheter. This kit was also returned to the manufacturer for evaluation. All BARD PICC kits in the organization, which included the Sherlock guidewire were pulled from stock and returned to the manufacturer for replacement stock.


Device:
Type: Ecg Data Management Database System
Manufacturer: GE Medical Systems Information Technologies
Brand: Muse
Model: MUSE
Other #: Current software version 7.1.1

Problem:
Patient 12 lead ECG Records found by edit lab staff in the MUSE unconfirmed report listing with inaccurate names assigned to records by automatic process in MUSE.

-Records transmitted to MUSE as PID: 999999999, Name: Absent.
-Records found in unconfirmed report listing as PID: 999999999, Name: lastname, firstname

Issue communicated to Biomed by the hospital's Cardio ECG Lab staff in mid 2008. Biomed later investigated and completed additional testing to confirm the reported issue.

Biomedical / clinical engineering: As hospital medical and information technology interface and share data, the integrity of each system's database becomes increasingly interdependent. It is necessary to develop an understanding of all data processes that occur before, during and following data acquisition and storage in order to verify patient record fidelity. This report details the characterization of improper automated hospital information systems data merges with regard to patient records in a GE Healthcare MUSE clinical database.

Initial discussions with GE: No corrections to the Normalization process would be made in Version 5 - will consider as a feature request for Version 7.

The problem is ongoing. The latest version (7.1.1) does not bring resolution to the issue. GE's response included recommendations for practice change, but did not specifically address the problem reported in any of the new versions (including 7).

GE has decided to make the concern a feature request. GE basically recommended that user always assigns the proper PID and name before transmission to the system. Do not confirm patient records containing default PID. Any combination of alphanumeric characters will be accepted as a valid PID. Determine if there are any existing confirmed records with PID sequences of all 9s or any other default PID as defined by your institution. To set defaults PID settings for your institution create a report for each default PID that contains that PID # and enter "Unknown patient" or similar in patient name field and confirm the report. Any subsequent records with a default PID and no patient name will now have name field populated with Unknown patient. This will alert user to the fact that record needs to be assigned correct patient demographics.

New logic should require a minimum of 2 patient identifiers for any merge to take place. Additional safeguards should be in place at 12 lead carts and bedside monitors that operate as sources of patient diagnostic information. These safeguards should limit the possibility for record export without adequate patient ID information.


Device:
Type: Port, Implanted
Manufacturer: AngioDynamics
Brand: Vortex Mp Port
Ref# MP-P5SAT
Other #: Size = 5 French

Problem:
Patient had a Vortex 5 French LP port placed in right chest on five months ago. The patient finished chemotherapy earlier this year and recently came in on for routine follow-up to the oncology clinic. The patient was complaining of pain around the right upper chest area. A blood draw could not be done from the Vortex port. A chest x-ray was done, which found the catheter broken off from the reservoir, which had migrated deep into the heart. The patient was taken to the cardiac cath lab, and the procedure for removing the catheter via right femoral artery by interventional cardiologist was successful. Subsequently, the reservoir was removed by surgeon. The catheter and reservoir was sent to pathology and a picture was taken (available upon request). The picture shows the catheter tubing is clearly broken off (not disconnected) about 0.5 cm from the reservoir. The patient was observed overnight and discharged home in stable condition.

See device image:

The picture shows the catheter tubing is clearly broken off about 0.5 cm from the reservoir.


Device:
Type: Pump, Infusion, Elastomeric
Manufacturer: Stryker Instruments
Brand: PainPump 2
Model: PainPump 2
Lot #: 10043022

Problem:
Stryker PainPump 2 filled with 400mL of medication, programmed and started. Immediately received "triangle E2" error message. Second pump filled, programmed and started without difficulty. Pump returned to Stryker for analysis.

This is one example in a series of ongoing problems. Over the past several months we have noticed an increase of problems with the Stryker Pain Pump 2 and BlockAid pumps. The problems have occurred with a variety of lot numbers and fall into three main groups:
1. programming issues (e.g. inability to program, or display of error messages when trying to program)
2. battery issues (e.g. pump would not turn on, stopped working, or displayed error message)
3. leaking issues (e.g. leaking at connector site). At least 18 pumps have been affected by these problems.

The events have occurred when the pumps were used for perineural applications, and have been experienced by several different clinicians at two different healthcare facilities. The pumps are all programmed at the hospital, and the problems are identified almost immediately. No patients have been harmed to date, although pain therapy has been delayed. We have been using this pump for several years, and these problems are reminiscent of the previous recall that Stryker issued in November 2008. We have returned all of the recent problematic devices to Stryker for evaluation.


OBSTETRICS/GYNECOLOGY

Device:
Type: Hydrothermablator
Manufacturer: Boston Scientific Corporation
Brand: Hydro Thermablator System (Hta System)
Model#: 56000
Cat #: 56000

Problem:
Patient for laparoscopic bilateral tubal ligation and hydrothermal endometrial ablation. Hydrothermal Ablation machine going through steps for hysteroscopic visualization. Fluid draining from visualization chamber going to collection bag, no fluid return from hysteroscope device. Fluid draining from IV bag supply into collection bag, not going through to the hysteroscope. Surgeon unable to adequately visualize cavity due to inadequate distention. Machine turned off, set-up steps repeated with same results. Sales representative called for troubleshooting; additional disposable devices obtained. Machine set-up with new disposable devices with same result. Laparoscopic procedure performed prior to ablation at this point, waiting for sales rep arrival. All steps repeated in presence of sales rep, who stated it is not turning on like it should, (talking about motor of machine) as computer components with appropriate displays present. Ablation performed using another system. Hydrothermalablator tagged, taken to desk for evaluation/repair. No harm to the patient. Substitute equipment used.


OPHTHALMIC

Device:
Type: Intraocular Lens Testing
Manufacturer: Carl Zeiss
Brand: Iolmaster
Model#: V 4.08

Problem:
IOL Master screening was done pre-op for cataract surgery, R eye reading accurate, L eye reading inaccurate but no alarm or highlight related to the size discrepancy. Cataract size ordered as indicated by test result and on post op day one patient found to have worse vision and it was determined that the wrong size lens was implanted.
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Health Professional's Impression
======================
Instead of rejecting a false measurement, the machine used it to incorrectly calculate a wrong lens implant size. This is because when the cataract is too dense, the IOLMaster can not give an accurate measurement. Instead of reporting an erroneous measurement, it should indicate the need for a different test. It may be helpful to allow for calibration of the software if the test is inaccurate. The physician realizes there are human factors involved but feels there could be an improvement to the software/reporting out of results.


ORTHOPEDIC

Device:
Type: Power Screwdriver
Manufacturer: Stryker
Model#: 4200A

Problem:
It was reported that there were two drills in use on the case: a two button model Stryker 4200A with separate buttons for forward and reverse modes, and a single button model that is repositioned to select forward or reverse modes. The MD primarily utilizes the two button drill. When drill was requested to remove the stabilizing screw from the cutting device (using the reverse mode), the scrub tech passed the single button drill and the MD inserted the screwdriver tip in contact with the screwhead and initiated the drill in the forward mode instead of using the reverse mode to back out the screw causing the screw tip (Zimmer part 6290-00-556) to break.
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Health Professional's Impression
======================
The MD inserted the screwdriver tip in contact with the screwhead and initiated the drill in the forward mode instead of using the reverse mode to back out the screw.


PHYSICAL MEDICINE

Device:
Type: Bed, Air Fluidized
Manufacturer: KCI USA, Inc
Brand: KinAir Medsurg
Model: KinAir Medsurg

Problem:
The wheels would not lock on a KCI low air loss bed in SICU. When care giver leaned on bed it would move easily. Mattress is such that when the mattress is on max inflate the patient slides easily on the mattress. Combined with the bed moving, both the care giver and the patient are at risk for injury.

Vendor personnel did demonstrate the proper procedure for locking the wheels however, only the wheels at the lower end of the bed lock. The two at the head end do not. Vendor personnel admitted this is true of all of these beds.

Co-workers confirmed they have the same issue in other rooms with similar beds.


Device:
Type: Wheelchair
Manufacturer: GF Health Products
Brand: E&j Traveler Xd

Problem:
Patient had just delivered a child and was being transferred from the labor and delivery room to a patient room. Patient was transferring from the wheelchair to the bed. During the transfer, the cushion which supports the leg on the right footrest was folded up. The patient's right leg caught on the bracket where the cushion attaches to the footrest. The patient sustained a laceration which required 36 sutures to repair. Patient received home health care post discharge.


RADIOLOGY

Device:
Type: MRI
Manufacturer: GE Medical Systems, LLC
Brand: Signa HDX
Model: Signa HDX

Problem:
Pressure plate (rupture disc) located directly above MRI unit had released helium gas into dedicated MRI duct system leading to the roof. The gas escaped out of the appropriate area.
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Health Professional's Impression
======================
During checks and analysis, we could not find a reason or cause for the "Quenching of the magnet." These things happen sometimes with reason, sometimes without. This one was one that has no reason that we can ascertain according to our analysis and investigating of the error logs of the system. The system is running well. This seldom happens, but we are continuing to do our daily checks to keep tabs on the system. The rupture disc burst, venting cryogenic helium into the outdoor atmosphere. We are not sure why it burst. There was no patient in the room at the time and, except for some water vapor that developed in the area surrounding the discharge duct (that leads to the rooftop hood), there did not seem to be any discharge into the room. There is a slight sulfur smell in the air that no one can identify. Two Clinical Engineering technicians are looking over the magnet and computer room and assure us that there is no danger present to anyone.


Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Medical Systems USA, Inc.
Brand: Philips Allura Integris 5000
Model#: Integris 5000

Problem:
In early September 2008, a contracted third party serviced the hospital's Philips Integris 5000 fluoroscopy unit in response to the annual regulatory radiation machine physicist's inspection. Several weeks later, a patient underwent cardiac ablation. The dosimeter report for a physician for this monitoring period indicated a high reading. The Physician stated that the badge was left by the source. Room monitoring badges and other EP staff badges were within the normal range. The subsequent dosimeter monitor report showed another high reading (level II) for the physician. The third party servicer was contacted for on-site service of the unit, and discovered that an internal "low dose" mode had been linked to the "high dose mode" during a prior service visit in mid September 2008 (by a technician working for the third party servicing company). Several months after the patient's ablation procedure, the patient's physician informed the hospital's Imaging Director of patient radiation burns and treatment. Hospital Risk Management has been in contact with the patient / spouse about family concerns.

Comment from FDA: MedSun has received additional reports with this product


MedSun Newsletters are available at www.fda.gov/cdrh/medsun