TRANSPORTER
Report
- Report Number
- 8010652-2024-00079
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- June 26, 2024
- Report Date
- July 5, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- BWN
- UDI-DI
- 04046768041059
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS - 118064B0 TRANSPORTER AND ITS BATTERY - 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION. AS IT WAS STATED, WHEN ATTEMPTING TO MOVE THE PATIENT INTO A FOOT-DOWN POSITION, THE "CHARGE TABLE SURFACE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND IT WAS NOT POSSIBLE TO TILT THE OPERATING TABLE TRANSPORTER. ACCORDING TO THE CUSTOMER'S ALLEGATION, THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. WHEN THE ISSUE OCCURRED, THE PATIENT WAS BEING PREPARED IN EMERGENCY (N01) FOR RE-LAPAROSCOPY FOR STENOSIS OF A GASTROJEJUNOSTOMY AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY. ACCORDING TO THE PROVIDED INFORMATION, IT WAS A TIME-CRITICAL INTERVENTION WITH RELEVANT FINDINGS AND THE PATIENT WAS AT MAXIMUM RISK OF ASPIRATION. RAPID SEQUENCE INDUCTION (RSI) IN THE FOOT-DOWN POSITION WAS PLANNED. DUE TO THE PROBLEM WITH THE EXISTING BATTERY, THE TIME WAS LOST AS THE STAFF HAD TO SEARCH FOR A NEW BATTERY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WERE TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR ISSUE OCCURRED. THE INFORMATION REGARDING THE SERIAL NUMBER OF THE INVOLVED TRANSPORTER WAS NOT NOTED BY THE CUSTOMER AND THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. THE INVOLVED BATTERIES WERE SENT TO THE MANUFACTURER FOR EVALUATION. ACCORDING TO THE PERFORMED ANALYSIS, NO ERRORS WERE FOUND. DISCHARGING OF THE BATTERIES WORKED WITHOUT ANY PROBLEMS. NO MALFUNCTION WAS CONFIRMED, AND THE BATTERIES WERE SENT BACK TO THE CUSTOMER. ACCORDING TO THE CUSTOMER'S ALLEGATION WHICH WAS CONFIRMED BY THE PROVIDED VIDEO EVIDENCE, THE "CHARGE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE WAS CONTACTED TO ASSESS THE MOST PROBABLE ROOT CAUSE OF THE ISSUE. AS IT WAS STATED BY THE SME, THE BATTERY LEDS DO NOT DISPLAY THE VOLTAGE, BUT THE REMAINING CAPACITY OF THE PACK. THE LED SWITCHES TO ORANGE WHEN THERE IS ONLY ENOUGH CAPACITY LEFT IN THE BATTERY FOR THE CURRENTLY RUNNING (ASSUMED) OPERATION. THE TABLETOP HAS NO COMMUNICATION WITH THE BATTERY AND USES ITS OWN VOLTAGE MONITORING SYSTEM THAT IS INDEPENDENT OF THE BATTERY DISPLAY. THIS IS ASSOCIATED WITH TOLERANCES AND MEASUREMENT INACCURACIES. WHEN UNDER LOAD, THE BATTERY VOLTAGE DROPS AND THE TABLE TOP REPORTS A LOW BATTERY LEVEL. WITH AGED CELLS, THE VOLTAGE DROP CAN BE GREATER, WHICH MEANS THAT THE TABLE TOP MESSAGE COMES SOONER. A BATTERY WITH A GREEN INDICATOR CAN SWITCH OFF DURING MOVEMENT IF THERE IS A SHORT CIRCUIT OR AN OVERLOAD OR IF ANOTHER SAFETY PARAMETER IS VIOLATED DURING MOVEMENT, E.G. THE TEMPERATURE. THE NORMAL SWITCH-OFF DUE TO AN OVERCURRENT WAS NOT RECORDED. THEREFORE, SWITCH-OFF DUE TO OVERTEMPERATURE (E.G. CAUSED BY CHARGER BEING PLACED BY THE WINDOW IN THE SUN OR ON THE HEATER) OR OVERLOAD COULD BE A POSSIBLE CAUSE. IN CASE OF THE BATTERY HEATED ABOVE THE LIMIT VALUE, RECOVERY AFTER SWITCHING OFF WOULD HAVE TAKEN A LITTLE LONGER THAN AFTER AN OVERCURRENT EVENT. HOWEVER, AS THIS TEMPORAL BEHAVIOR IS CURRENTLY NOT KNOWN, IT HAS BEEN CONCLUDED THAT THIS IS ONLY A THEORETICAL POSSIBILITY. THE MOST PLAUSIBLE EXPLANATION WOULD BE THAT THE BATTERY WAS ALREADY QUITE DISCHARGED (BUT NOT YET BELOW THE THRESHOLD FOR THE YELLOW LED). THE TABLE TOP HAD ALREADY ESTIMATED A LOWER STATE OF CHARGE DUE TO THE MEASUREMENT PROBLEMS MENTIONED ABOVE. IN THAT CASE, A SLIGHTLY HEAVIER LOAD COULD CAUSE THE BATTERY VOLTAGE TO COLLAPSE TO THE EXTENT THAT THE BATTERY SWITCHES OFF DUE TO OVERLOAD. AS STATED IN THE INSTRUCTIONS FOR USE, BATTERIES MAY BE WARMED UP BY EXPOSITION TO DIRECT SUNLIGHT (GA 1009.75 EN 06 PAGE 7). THE USER IS WARNED NOT TO EXPOSE THE BATTERIES TO DIRECT SUNLIGHT, NOT TO HEAT THE BATTERY ABOVE 60 °C AND NOT TO RECHARGE A HOT BATTERY (GA 1009.75 EN 06 PAGE 7). THE USER IS INFORMED THAT THE RECHARGEABLE BATTERY WILL BE SWITCHED OFF IN THE EVENT OF OVERLOADING IN ORDER TO PROTECT IT. OVERLOADING MAY BE CAUSED BY EXCESSIVE WEIGHT (E.G. PATIENT TOO HEAVY), ON THE COMPONENT(S) TO BE ADJUSTED. THE USER IS ADVISED TO REDUCE THE WEIGHT (E. G. ACCESSORIES) (GA 1009.75 EN 06 PAGE 15). IN SUMMARY, AS THEORETICAL SCENARIOS COULD NOT BE FURTHER CONFIRMED, IT WAS CONCLUDED THAT THE ROOT CAUSE OF THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WAS IMPOSSIBLE TO DEFINE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. INITIAL REPORTER: MEDICAL TECHNOLOGY DEPARTMENT THE FULL UNIQUE IDENTIFIER (UDI) # INFORMATION AND MANUFACTURING DATE ARE NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D4 UNIQUE IDENTIFIER (UDI) #, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H6 HEALTH EFFECT ¿ IMPACT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 1ST JULY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS - 118064B0 TRANSPORTER AND ITS BATTERY - 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION. AS IT WAS STATED, WHEN ATTEMPTING TO MOVE THE PATIENT INTO A FOOT-DOWN POSITION, "CHARGE TABLE SURFACE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND IT WAS NOT POSSIBLE TO TILT THE OPERATING TABLE TRANSPORTER. ACCORDING TO CUSTOMER ALLEGATION, THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. WHEN THE ISSUE OCCURRED, THE PATIENT WAS BEING PREPARED IN EMERGENCY (N01) FOR RE-LAPAROSCOPY FOR STENOSIS OF A GASTROJEJUNOSTOMY AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY. ACCORDING TO PROVIDED INFORMATION, IT WAS TIME-CRITICAL INTERVENTION WITH RELEVANT FINDINGS AND THE PATIENT WAS AT MAXIMUM RISK OF ASPIRATION. RAPID SEQUENCE INDUCTION (RSI) IN FOOT-DOWN POSITION WAS PLANNED. DUE TO THE PROBLEM WITH EXISTING BATTERY, THE TIME WAS LOST AS THE STAFF HAD TO SEARCH FOR A NEW BATTERY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WERE TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS - 118064B0 TRANSPORTER AND ITS BATTERY - 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION. AS IT WAS STATED, WHEN ATTEMPTING TO MOVE THE PATIENT INTO A FOOT-DOWN POSITION, THE "CHARGE TABLE SURFACE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND IT WAS NOT POSSIBLE TO TILT THE OPERATING TABLE TRANSPORTER. ACCORDING TO THE CUSTOMER'S ALLEGATION, THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. WHEN THE ISSUE OCCURRED, THE PATIENT WAS BEING PREPARED IN EMERGENCY (N01) FOR RE-LAPAROSCOPY FOR STENOSIS OF A GASTROJEJUNOSTOMY AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY. ACCORDING TO THE PROVIDED INFORMATION, IT WAS A TIME-CRITICAL INTERVENTION WITH RELEVANT FINDINGS AND THE PATIENT WAS AT MAXIMUM RISK OF ASPIRATION. RAPID SEQUENCE INDUCTION (RSI) IN THE FOOT-DOWN POSITION WAS PLANNED. DUE TO THE PROBLEM WITH THE EXISTING BATTERY, THE TIME WAS LOST AS THE STAFF HAD TO SEARCH FOR A NEW BATTERY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WERE TO REOCCUR. PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H6 HEALTH EFFECT ¿ IMPACT CODES: SURGICAL INTERVENTION/PROLONGED SURGERY - 4632. CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: DELAY TO TREATMENT/ THERAPY - 4604.
ON 1ST JULY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS - 118064B0 TRANSPORTER AND ITS BATTERY - 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION. AS IT WAS STATED, WHEN ATTEMPTING TO MOVE THE PATIENT INTO A FOOT-DOWN POSITION, "CHARGE TABLE SURFACE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND IT WAS NOT POSSIBLE TO TILT THE OPERATING TABLE TRANSPORTER. ACCORDING TO CUSTOMER ALLEGATION, THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. WHEN THE ISSUE OCCURRED, THE PATIENT WAS BEING PREPARED IN EMERGENCY (N01) FOR RE-LAPAROSCOPY FOR STENOSIS OF A GASTROJEJUNOSTOMY AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY. ACCORDING TO PROVIDED INFORMATION, IT WAS TIME-CRITICAL INTERVENTION WITH RELEVANT FINDINGS AND THE PATIENT WAS AT MAXIMUM RISK OF ASPIRATION. RAPID SEQUENCE INDUCTION (RSI) IN FOOT-DOWN POSITION WAS PLANNED. DUE TO THE PROBLEM WITH EXISTING BATTERY, THE TIME WAS LOST AS THE STAFF HAD TO SEARCH FOR A NEW BATTERY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WERE TO REOCCUR.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TRANSPORTERS - 118064B0 TRANSPORTER AND ITS BATTERY - 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION. AS IT WAS STATED, WHEN ATTEMPTING TO MOVE THE PATIENT INTO A FOOT-DOWN POSITION, THE "CHARGE TABLE SURFACE BATTERY" MESSAGE WAS DISPLAYED ON THE WIRED REMOTE CONTROL AND IT WAS NOT POSSIBLE TO TILT THE OPERATING TABLE TRANSPORTER. ACCORDING TO THE CUSTOMER'S ALLEGATION, THE BATTERIES STILL SHOWED READINESS FOR USE WITH THE GREEN LED DISPLAY. WHEN THE ISSUE OCCURRED, THE PATIENT WAS BEING PREPARED IN EMERGENCY (N01) FOR RE-LAPAROSCOPY FOR STENOSIS OF A GASTROJEJUNOSTOMY AFTER ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY. ACCORDING TO THE PROVIDED INFORMATION, IT WAS A TIME-CRITICAL INTERVENTION WITH RELEVANT FINDINGS AND THE PATIENT WAS AT MAXIMUM RISK OF ASPIRATION. RAPID SEQUENCE INDUCTION (RSI) IN THE FOOT-DOWN POSITION WAS PLANNED. DUE TO THE PROBLEM WITH THE EXISTING BATTERY, THE TIME WAS LOST AS THE STAFF HAD TO SEARCH FOR A NEW BATTERY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE INABILITY TO POSITION THE PATIENT AND DELAY IN EMERGENCY SURGERY, WERE TO REOCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466344 | TRANSPORTER | TABLE AND ATTACHMENTS, OPERATING-ROOM | BWN | MAQUET GMBH | 118064B0 | 04046768041059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | 100975A0 LI-ION BATTERY WITH CHARGING INDICATION. |