Highlighted Reports
MedSun: Newsletter #73, June 2012

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 March 1 through March 31, 2012. 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.

CARDIOVASCULAR

Device:
Type: Laser, Transmyocardial Revascularization
Manufacturer: Cardiogenesis Corporation
Brand: Sologrip Iii
Model#: 705-37020
Lot #: TA-03797

Problem:
Circulator attempted to open outside packaging to deliver tray with the instrument to the sterile field. In doing so, the peel-away corner of outer wrap either bent back or otherwise made RN think that the inner package had been contaminated. The inner package has semi-rigid tray with a cover (both plastic) that is in turn covered with a peel-back plastic-like covering layer. RN would normally never remove this peel-back covering but would hand tray over using outer paper packaging. Because this product costs $6,000, the RN attempted to peel off the inside cover so she could hand over the tray in open condition. The catheter in the tray flipped out of the packaging and was contaminated. Therefore the product was unusable. Photos can be supplied to demonstrate the conditions.
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Manufacturer response for Laser catheter to create new cardiac collateral circulation (TMR), Sologrip III 43% (per site reporter)
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"Have never seen this happen before."


Device 1:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Solar 8000i
Model#: Solar

Device 2:
Type: Monitor, Physiological, Module
Manufacturer: GE Healthcare
Brand: Patient Data Module (Pdm)
Model#: PDM
Other #: Software Version 1.4

Problem:
During the course of routine general anesthesia, the noninvasive blood pressure monitor (NIBP or NBP) which was set to Auto mode with 2.5 minute interval stopped cycling without warning, notification, or apparent cause.
The monitor was GE Solar 8000i with a PDM (multi-parameter module) with Version 1.14 software. The software version was confirmed with photo of same because software version 2.0 was known to have this problem and was recalled and was removed from use in this hospital. Two physicians observed that there was no blood pressure measured for nine (9) minutes and used the control knobs and touch screen to turn the NIBP back to Auto mode and reset the interval to 2.5 minutes. The location was in an OR. We downgraded our PDM software to version 1.4 and are still seeing the same problem with the PDM's in the OR.
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Manufacturer response for Noninvasive blood pressure monitor, Patient Data Module (PDM) software version 1.4 and Solar 8000i (per site reporter)
======================
We have not let the manufacturer aware as of yet; however, we will after this is submitted.

Device:
Type: Pacemaker, Implantable
Manufacturer: Medtronic, Inc.
Brand: Sigma 300 Dr
Model#: SDR303B

Problem:
The patient's pacemaker was implanted 6 years ago. As the pacer was nearing end of life, the patient was transmitting data monthly via telephone. The patient placed a transmission device over the pacer and the pacer stopped working. The patient passed out and awoke as the transmission device fell away. He was brought to an outside hospital. A tech rep met the patient at the outside hospital ED and attempted to interrogate the device. The device malfunctioned and the patient became asystolic for approximately 10 seconds and passed out. The device was moved away from the pacer and it resumed working and the patient awoke. This patient is pacer dependent. The patient was transferred to the hospital for pacer placement. He underwent the procedure and has been discharged home. The pacer and leads (Pace Setter 1388TC were given to the Medtronic rep).
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Manufacturer response for Pacemaker, Sigma (per site reporter)
======================
No response yet


EAR, NOSE, & THROAT

Device:
Type: Nasal Packing Foam
Manufacturer: Gyrus ACMI
Brand: Posisep X
Lot #: 1110760A
Cat #: 9210584

Problem:
A trial of a new product that had shellfish ingredients (internal nasal sinus surgery dressing/foam) was applied after the surgery was done as per instructions from the doctor. No one was aware the product had shellfish product until after the surgery was completed. Patient is allergic to shellfish.

The vendor, Gyrus ACMI, notified Dr. after the surgery was done that the trial product has small amounts of shellfish derivative in it. Dr. immediately returned to O.R. to remove the packaging. The patient had no symptoms or signs of allergic reaction during his stay. The patient was monitored and observed per Doctor's orders then discharged home. This packaging comes in a container with five individual packs. The complaint from the staff was they did not know the product contained shellfish derivatives. After conferring with the manufacturer it was discovered the packaging did indicate it had shellfish derivatives, but it is hard to find on the packaging. The suggestion is this caution needs to be more visual.
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Manufacturer response for Nasal packing foam, Posisep X (per site reporter)
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Reported this issue to the manufacturer through the local sales rep. We were told he will write up the report and email a copy to our facility. Nothing received at present.


GENERAL &PLASTIC SURGERY

Device 1:
Type: Clip Applier
Manufacturer: Covidien
Brand: Autosuture Endoclip Ii
Lot #: NIE0799
Cat #: 176657

Device 2:
Type: Clip Applier
Manufacturer: Covidien
Brand: Autosuture Endoclip Ii
Lot #: J2A0004X
Cat #: 176657

Problem:
During a laparoscopic cholecystectomy, the endoclip applier times two was not operating properly; the clips dropped out. Retrieved clips that did not close and replaced clip applier with one that did function correctly. Instrument involved was reference number 176657 (10 mm medium/large clip), lot# J2A0004x and NLE0799. All clips were retrieved under visualization. There was no harm to the patient.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180

Problem:
During robotic assisted total hysterectomy with right salpingo-oophorectomy, the PA reported that an arc was seen coming from the da Vinci monopolar curved scissors tip cover accessory. No flame seen.

Instrument removed and tip cover replaced with a new one. Procedure resumed. No further incidents. QA performed a FDA Maude database search for similar reported problems across the United States. We found many reports regarding tears and holes in the Monopolar Tip cover Insulator accessory part # 400180 used with the Curved Scissors which resulted in some situations arcing or energy being delivered to unintended nearby tissue.

Intuitive Surgical had sent a Customer Safety Notice Letter in October 2011 to customers with Safety Recommendations and Suggestions to prevent this situation from occurring. The main bullet points from the letter to minimize this risk are:

*Avoid Instrument Collisions.
*Carefully Install the Tip Cover.
*Straighten wrist prior to removal.
*Inspect cannula prior to use.
*Do not exceed maximum monopolar cautery settings.
*Only use Validated ESUs.
*Be aware of critical anatomy in contact with the instrument.
*Change Tip Cover in cases with extended cautery use.

Each of bullet items listed above has detailed explanations in the letter. This information has been shared with Surgical Services Management and Administration.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180

Problem:
During procedure monopolar curved scissors (hard shears) #420179 was used and electrical arc was observed to uterus by PA and physician.

Scissor and tip were removed. A round hole was seen by scrub technician and circulator in tip cover. We put new tip cover accessory on scissor, no hole was observed and we continued with procedure, without difficulty (slight burn to uterus from arc, but uterus removed in scheduled surgical procedure), so no harm was done to patient.

QA performed a FDA Maude database search for similar reported problems across the United States. We found many reports regarding tears and holes in the Monopolar Tip cover Insulator accessory part # 400180 used with the Curved Scissors which resulted in some situations arcing or energy being delivered to unintended nearby tissue.

Intuitive Surgical had sent a Customer Safety Notice Letter in October 2011 to customers with Safety Recommendations and Suggestions to prevent this situation from occurring. The main bullet points from the letter to minimize this risk are:

*Avoid Instrument Collisions.
*Carefully Install the Tip Cover.
*Straighten wrist prior to removal.
*Inspect cannula prior to use.
*Do not exceed maximum monopolar cautery settings.
*Only use Validated ESUs.
*Be aware of critical anatomy in contact with the instrument.
*Change Tip Cover in cases with extended cautery use.

Each of bullet items listed above have detailed explanations in the letter. This information has been shared with Surgical Services Management and Administration.


Device 1:
Type: Ligature Loop, Endoscopic
Manufacturer: Ethicon Inc.
Brand: Endoloop W/coated Vicryl
Model#: EJ10.01
Lot #: CMS273

Device 2:
Type: Ligature Loop, Endoscopic
Manufacturer: Ethicon Inc.
Brand: Endoloop W/coated Vicryl
Model#: EJ10.01
Lot #: AHX032

Problem:
OR nurse opened two new packages of Endoloop Ligature made with coated Vicryl and discovered the foil packaging had pin prick holes in them. Because the packages had holes this compromised the sterility of the device. The packaging and devices were sequestered. Manufacturer notified. This incident is not new to our facility. We have reported this same incident over a month ago. We have reported at least 5 incidents related to this type of packaging. The other incidents were Endoknot products from the same company; it appears this packaging is not durable enough. Since this is not new to our facility the OR nurses are now checking every single package before they use the device to ensure the sterility of the device. Nurses should not be doing this time consuming process.


Device:
Type: Medline Sterile Drape
Manufacturer: Medline Industries, Inc.
Brand: Medline CSection Sterile (Pack)
Lot #: 11LB2814

Problem:
After start of cesarean section, drape was noted to have large opening at the seam across the patient's chest. Sterile towels were used to cover the area. MD ordered additional antibiotics for the patient post-op.


Device 1:
Type: Renal Vein Retractor
Manufacturer: Omni-Tract Surgical
Brand: Renal Vein Retractor 1" X6"
Cat #: 3101

Device 2:
Type: Splanchnic Retractor
Manufacturer: Omni-Tract Surgical
Brand: Splanchnic Retractor 2" X6"
Cat #: 3099

Problem:
Female patient with severe degenerative disease of the spine underwent an anterior exposure of the spine L4 - L5 - S1 spaces for spinal fusion. Surgery and immediate post-operative recovery were unremarkable. She was re-hospitalized the following week with left ureteral injury which required transfer to tertiary care center for surgical repair of her left ureter.


Device 1:
Type: Stapler, Anvil Assembly
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series Orvil
Model#: EEAORVIL21
Lot #: N1K0120U
Cat #: EEAORVIL21

Device 2:
Type: Stapler, Anvil Assembly
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series Orvil
Model#: EEAORVIL21
Lot #: N1E0393U
Cat #: EEAORVIL21

Device 3:
Type: Stapler, Surgical
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series
Model#: EEAXL21
Cat #: EEAXL21

Device 4:
Type: Stapler, Surgical
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series
Model#: EEAXL21
Cat #: EEAXL21

Problem:
First case; EEAORVIL21 anvil assembly is the product. This OrVil device would not mate to the EEAXL21 stapler. Upon inserting a new OrVil device the two did mate and the case was completed.

Second case; EEAORVIL21 anvil assembly is the product. This OrVil device again would not mate to the EEAXL21 stapler. Upon inserting a new, second OrVil device, there appeared to some mating issues upon the onset of use of the second OrVil, but then they did connect and we were able to fire the stapler. The firing did not result in a complete anastomosis. The surgeon was required to over sew the anastomosis. Over-sewing was done laparoscopically. Upon performing a leak test, there were bubbles which indicated that the anastomosis was still not complete, which resulted in the surgeon deciding to open in order to gain the needed access to the site for repair of the anastomosis.
The OrVil in the first case has been set aside for a return to Covidien. Both OrVil's and the EEA stapler that was utilized in the second case have been set aside to be returned to Covidien. I have filled out Covidien Field Technical Reports for both cases and will provide a FTR number as soon as I receive it. Covidien will send a box to put all the products in for a shipment back to Covidien Quality Assurance Department. Let me know if you need any additional information and I will provide that to you.


GENERAL HOSPITAL

Device:
Type: Catheter, Intraspinal
Manufacturer: Medtronic
Brand: Intrathecal Indura 1p
Lot #: N310091010
Cat #: 8709SC

Problem:
Patient with metastatic breast cancer, and a history of chronic opiate use, is now status post intrathecal pump placement. She was doing well on morphine and bupivacaine, however, recently had a dramatic increase in her pain.
She underwent a side port study under fluoroscopy guidance a few weeks ago, which demonstrated a functioning pump, from which CSF was not able to be aspirated. The catheter lead appeared to have migrated out of the intrathecal space. At that point she was scheduled for an operating room revision of the indwelling intrathecal catheter.


Device:
Type: Catheter, Intravascular, Short
Manufacturer: BD
Lot #: 1339507

Problem:
RN started the IV with a 20 qauge BD Nexiva IV start kit just above the patient's left wrist. Before I hooked it up to the primary bag tubing and the patient, a few drops of blood was noticed on the tubing connected to the hub. There was a tiny hole there which was dripping blood. I removed the IV, and checked the next kit before I started the IV. There was a visible hole in the tubing in that one as well.
I had to use a different type IV that is now connected and infusing well.


Device:
Type: Catheter, Iv
Manufacturer: Smiths Medical
Brand: Jelco
Lot #: ST2139217
Cat #: 3067

Problem:
While placing an IV catheter, the nurse tried to fully retract the introducer needle by sliding back the grip pads. However, they appeared to stick before reaching the full extent of their travel. When the needle guard and hub were removed from the catheter, the introducer needle was still exposed, presenting needle stick hazard.


Device:
Type: Catheter, Picc
Manufacturer: Angiodynamics
Lot #: R43455
Cat #: 12102618

Problem:
This involved a triple lumen PICC. Unable to advance catheter over nitinol wire included in PICC kit. Access maintained, new kit opened and PICC placed without further difficulty. No adverse effects or complaints from patient. Supply sent to Materials Management and Angiodynamic Rep notified of issue. Will meet to identify alternative wires to replace nitinol coated wire in triple lumen PICC kit.


Device:
Type: Catheter, Port, Implanted
Manufacturer: Bard Access Systems, Inc.
Brand: Powerport
Lot #: REVI0840
Cat #: 1808060

Problem:
Port catheter had to be removed due to leaking. Upon removal, a longitudinal fracture halfway between the port and tip was noted.


Device:
Type: Closed Iv Catheter System
Manufacturer: BD Medical
Brand: Bd Nexiva
Model#: 383537
Lot #: 1333507
Cat #: 383537
Other #: N/A

Problem:
When IV inserted into patient, the blood started flowing into tubing and then started running all over the bed. Upon inspection there was a hole in the tubing where the clamp sits. The patient was stuck another time due to defective tubing. Prior to use on two more patients in the same department, the same problem occurred. Additionally, three more problems were found for a total of six problems. The devices were returned to the manufacturer for evaluation. Due to numbers, the entire lot# was pulled from use in the facility. There were more found where the defect could be seen while in the packaging. Not every product in the lot was affected at least visually, but all were pulled as a precaution and replaced by BD. All cuts in tubing are in the same exact location on all samples.

NEUROLOGY

Device:
Type: Rongeur
Manufacturer: Aesculap, Inc.
Brand: Kerrison Rongeur
Model#: AESCULAP FF 661R

Problem:
A lumbar laminectomy tray was opened in the OR suite and it was noted the Kerrison Rongeur had tried bone in the tip of the instrument. This particular model does not come apart. The instrument had been cleaned prior to the procedure per the manufacturer's recommendations. There are no special cleaning tools that are provided with this device. This instrument did not reach the patient.


Device:
Type: Stimulator, Vagus Nerve
Manufacturer: Cyberonics, Inc.
Brand: Vagus Nerve Generator
Model#: 103

Problem:
Upon evaluation of patient, doctor identified that the patient's vagal nerve stimulator was reporting out a very high impedance -specifically greater than 10,000 ohms. This is an unacceptably high impedance from the binary report on the device test. The device did not appear to be at the end of its service life


Device:
Type: System, Eeg Monitoring
Manufacturer: Natus Medical Incorporated
Brand: Stellate
Model#: HSYS-REC-EAMP
Other #: hospital tag 208241

Problem:
Patient was undergoing long term (several days) EEG monitoring on a patient floor. At some point, the patient was leaving to use the restroom within the patient room and the EEG data stopped being captured although the equipment remained in the record mode. The nurse paged the EEG tech and he unplugged and re-seated different connections. Some miscommunication occurred between the nurse and the EEG tech and each felt the problem was resolved but in fact it was not. The following morning the neurologist was attempting to review the study and found no brain activity recorded. This time the 'head box' and 'connections' were re-seated AND the machine was re-booted and the equipment operated fine. The OEM trained biomed investigated and in his opinion, determined that the head box was disconnected upon the patient's trip to the bath room which caused a 'glitch' in the software that did not re-initialize so the PC continued to record zero signal. His alternate theory is that the head box may never have been plugged back in. This incident was not reported to clinical engineering because the EEG and nursing staff felt the problem was simple and was resolved easily. I am reporting this almost a year post incident. I don't know for sure if this was a software glitch or human error. We could not reproduce the problem. The equipment has run for 12 months without further incident.


Device 1:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 207642

Device 2:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 207667

Device 3:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 208040

Problem:
Reported to the Clinical Engineering manager that "Nicolet EEG equipment is frequently bumped off line, several times per day, in the middle of procedures...in the OR during cases... We've been working directly with the OEM under our contract... FYI

"The Clinical Engineering manager promptly visited and asked the staff to complete incident reports every time this occurs and to please notify us to work with both the OEM and the hospital’s Network Teams in order to resolve this."

OPHTHALMIC

Device:
Type: Constellation
Manufacturer: ALCON LABORATORIES INC (SURGICAL DIVISION)
Brand: 25+ Totalplus Vitrectomy Pak
Lot #: 1245923H
Cat #: REF 8065751462

Problem:
OR nurses had set up for a 25 gauge vitrectomy with our new Constellation machine. The machine had been primed and calibrated. The patient was brought into the room, prepped and draped. The surgeon started the case and said that the 25 gauge vitrector was not working correctly. We do not have 25 vitrectors separately, so another set up was obtained. We replaced the vitrector, re-primed etc. The machine noted low cut rate vitrector and the machine still did not work correctly. Additional help for third set-up was called. Help came in and opened yet another 25 gauge set up. This set up was re-primed and it worked.


ORTHOPEDIC

Device:
Type: Application, Fixation, Spinal
Manufacturer: Stryker Corporation
Brand: Reflex Hybrid Revision Driver Draw Rod
Lot #: 109527
Cat #: 48511906B

Problem:
The tip of Stryker Revision Driver Draw Rod broke off in screw during anterior cervical diskectomy. Screw removed with tip of driver in place. No foreign body retained in patient. No patient harm.


Device:
Type: Curette, Vertebroplasty
Manufacturer: Medtronic, Inc.
Brand: Kyphon Express Curette
Model#: A13A
Lot #: unk
Cat #: A13A

Problem:
Patient was undergoing kyphoplasty of thoracic 10 and 12 for vertebral body fracture, osteoporosis and low back pain. A core biopsy of the thoracic 10 vertebral body was taken. The space was drilled and a curette was used to enlarge the space. The curette broke, "would not fire", and had shirring. The surgeon felt the curette was problematic. No patient injury sustained.


RADIOLOGY

Device:
Type: Linear Accelerator
Manufacturer: Varian Medical Systems, Inc.
Brand: Varian Ix-s
Model#: Ix-S
Other #: B300487

Problem:
A patient was scheduled for external beam radiation therapy on a medical linear accelerator (LINAC). As part of the set up for treatment, orthogonal X-ray images of the patient are acquired. The LINAC involved has an on-board imaging (OBI), consisting of an X-ray source and digital X-ray detector, system mounted on the LINAC gantry. The source and detector are mounted on retractable arms which are extended for imaging and retracted for treatment. After taking orthogonal X-ray images, the X-ray tube arm was directly over the patient. Therapists were outside the room at the treatment console. Therapists started to retract the OBI and noticed device errors as well as the device going in the wrong direction. Upon entering the room, the X-ray tube support assembly was observed to have descended to within 6 inches of the patient. There was no harm to the patient. The motion was not expected and was traced to a failed motor assembly in the X-ray tube support arm.


Device:

Type: Media, Coupling, Ultrasound
Manufacturer: Pharmaceutical Innovations, Inc.
Brand: Other-sonic
Model#: NDC 36-1111-25
Other #: 250 mL

Problem:
In late December 2011, the Department of Epidemiology identified an increase in the number of patients undergoing surgery who developed colonization or infection with P. aeruginosa. An immediate investigation was begun. The patients were localized to one unit, among patients undergoing cardiovascular surgery. Colonization/infection was confined to the respiratory tract. No surgical wound infections, device-associated infections, or bloodstream infections were identified.

A total of 16 patients eventually were found to harbor P. aeruginosa. The majority of cases were either asymptomatic (colonized) or had mild tracheobronchitis. Molecular typing of 10 case isolates were similar. Dates of onset were from early December, 2011 through mid-January of 2012. Cases were found to be more likely to have TEE probes in place for longer periods of time than non-cases. Therefore, the TEE probes were inspected and cultured - all culture results were negative. Since TEE probes are inserted with an ultrasound transmission gel, the 250mL dispensers of "bacteriostatic" ultrasound transmission gel were removed from all OR's as a precaution and replaced with single dose sterile ultrasound gel (pending culture results). After this intervention, no further cases developed.

The 250mL dispensers of "bacteriostatic" Other-Sonic ultrasound gel manufactured by Pharmaceutical Innovations, Inc., Newark, NJ (Ref #NDC 36-1111-25) were cultured and found to harbor various organisms including P. aeruginosa matching the case strain by molecular typing. Unopened bottles of Other-Sonic gel were cultured as well to exclude intrinsic contamination. At least 2 of the sealed bottles are growing microorganisms (presumptively, P. aeruginosa) to date.

The hospital has internally recalled the Other-Sonic gel in question in mid-February of 2012.


Device:
Type: Nuclear Gamma Camera
Manufacturer: Philips Medical Systems
Brand: Brightview
Model#: 50084759

Problem:
Patient was on imaging table having nuclear stress test pictures. Patient's arm became wedged in detector. Sensor did not engage and stop camera. Patient was eventually freed from camera but stated she then had left arm pain.

Vendor completed service call. Tested camera under same conditions to ensure that motion would stop when a collision is detected. Pressed on the corner or edges of the collimators at 90 degrees and did not cause collision detection. When the collimator FOV (field of view) was pressed, instead the black outline, all motions stopped. The areas that are not sensitive on the collimator face and edge are due to electronics being housed inside those areas. The electronics are related to auto body contouring. A customer complaint about the collimator design and an incident report about the patient collision have been submitted to the manufacturer.


Device:
Type: Shield, X-ray, Mobile
Manufacturer: Fluke Biomedical (formerly Nuclear Associates)
Brand: Clear-pb Mobile Barriers
Model#: 56-604

Problem:
The patient was undergoing coronary angiography. The attending physician was walking across the procedure room in order to insert some documents into the patient's chart. Since fluoroscopy was ongoing, he was moving the mobile x-ray shield across the room so that he would remain behind it. Just after he let go, the upper portion of the window snapped off just above the vertical mounts on both sides. The cracked edge was smooth but not sharp like glass. The piece that fell to the floor did not shatter nor strike anyone or anything that would have compromised the procedure.

Staff fortunately saved the two parts of the broken window. It's made of plastic, not glass so the part that fell didn't shatter. The device is considered a radiation safety device by the manufacturer. My opinion is that there was a notch near one of the side support channels and that the continued flexing and handling of the unsupported upper portion of the window over a long period of time resulted in a crack growing from the notch until this catastrophic event occurred.


Device:
Type: X-ray System, Cath/angio
Manufacturer: GE Healthcare
Brand: Innova
Model#: 2320045-5

Problem:
Patient on table for Cardiac Cath Lab procedure, but procedure had not started. Table instantly dropped, falling abruptly. No one was near table to accidentally press buttons or levers. Attempted to raise table to proper height again, and the same thing happened. No adverse outcome.

GE Healthcare replaced the table lift assembly to repair the issue.



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