HYBRID OR TABLE COLUMN, SURFACE-MOUNTED
Report
- Report Number
- 3013876692-2022-00026
- Event Type
- Death
- Date Received
- April 25, 2022
- Date of Event
- April 18, 2022
- Report Date
- February 10, 2023
- Manufacturer
- HOLGER ULLRICH
- Product Code
- FQO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AT THE TIME OF THIS REPORT, THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THE FULL EVENT SITE NAME (B)(6).
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
GETINGE BECAME AWARE OF AN ISSUE WITH 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. DURING THE SURGERY WITH THE GETINGE DEVICE AND SIEMENS ANGIOGRAPHY SYSTEM, THE SIEMENS SYSTEM GOT LOCKED AND MAGNUS TABLE OR SIEMENS ANGIOGRAPHY SYSTEM COULD NOT BE MOVED. THE SIEMENS ANGIOGRAPHY SYSTEM WAS IN THE WAY OF CARDIOPULMONARY RESUSCITATION. IN THE COURSE OF THE SURGERY, THE PATIENT HAD A CARDIAC ARREST, WHICH RESULTED IN THE PATIENT'S DEATH. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN ON SITE. THE HEIGHT POTENTIOMETER WITH CABLE, HYBRID-OR INTERFACE AND TREND SENSORS WERE REPLACED. THE TECHNICIAN FOUND ALSO AN EXTERNAL LEAK ON THE TRENDELENBURG CYLINDER AND REPLACED A DEFECTIVE SEALING. THE AFFECTED ELECTRONIC PARTS WERE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. BASED ON THE EXAMINATION PERFORMED BY PROCESS ASSURANCE, THE RETURNED PARTS WERE RULED OUT AS A POTENTIAL CAUSE OF THE INCIDENT. A DETAILED ANALYSIS PERFORMED BY THE MANUFACTURER AS A PART OF CORRECTIVE AND PREVENTIVE ACTIONS (CAPA 2022-007) REVEALED THAT AN EXTERNAL LEAK WAS THE RESULT OF A DAMAGED U-SIT RING (SEALING RING) ON THE TRENDELENBURG CYLINDER. IN THE COURSE OF PERFORMED INVESTIGATION IT TURNED OUT THAT PRIOR TO THIS EVENT (ON 18TH SEPTEMBER 2021) THE TECHNICIAN PERFORMED A FIELD ACTION CAPA 2020-013 RELATED TO THE TRENDELENBURG CYLINDER LEAKAGE CAUSED BY A DAMAGED HYDRAULIC LINE. AS THERE WAS NO FURTHER SERVICE WORK PERFORMED BETWEEN REPAIR RELATED TO FIELD ACTION AND THE REPORTED INCIDENT IT COULD BE ASSUMED THAT THE SEAL WAS DAMAGED WHEN THE LOCKING RING WAS ATTACHED OR WHEN THE HYDRAULIC LINE WAS LOOSENED. PER THE AVAILABLE SERVICE MANUAL (TR 118001B2 EN 06, PAGES 161-164) THE SEALING RINGS HAVE TO BE REPLACED WHILE THE WORK ON HYDRAULIC LINE IS PERFORMED (IF THE HOLLOW BOLTS ARE DISMOUNTED AND AFTERWARD FIXED AGAIN). IN SUCH SCENARIO, THE DAMAGED U-SIT RING DOES NOT SEAL PROPERLY WHICH RESULTS IN OIL LEAKING AT THE TRENDELENBURG CYLINDER, RUNNING DOWN THE HYDRAULIC LINE AND DRIPPING INSIDE THE OR COLUMN. IN CONCLUSION, A SMALL MOVEMENT TRIGGERED BY THE HYDRAULIC LEAKAGE RESULTS IN A SENSOR SIGNAL OUT OF THE ALLOWED CALCULATED RANGE BY THE ANGIOGRAPHY SYSTEM. SUBSEQUENT ERROR MESSAGE LEADS TO MOVEMENT RESTRICTIONS - BLOCKING ALL MOTORIC AIDED OR-TABLE, THUS THE FAILURE MODE THAT HAS HAPPENED IN THIS INCIDENT. IN THE USER MANUAL THE USER CAN FIND INFORMATION WHAT TO DO IF THE MAGNUS TABLE COLUMN WILL BE BLOCKED BY THE SIEMENS ANGIOGRAPHY SYSTEM. IN THE IFU (IFU 1180.01 EN 33, PAGE 146) IT IS STATED THAT IF THE HYBRID OPERATING TABLE IN EXAMINATION MODE CANNOT BE OPERATED AT ALL OR IN A RESTRICTED MANNER ONLY, THIS MAY BE CAUSED BY PROBLEMS REGARDING THE INTERFACE SOFTWARE BETWEEN THE HYBRID OPERATING TABLE AND THE ANGIOGRAPHY SYSTEM. THE USER IS INFORMED THAT IN SUCH A SITUATION THE ANGIOGRAPHY SYSTEM SHOULD BE SWITCHED OFF AND ON AGAIN. IF THE PROBLEM STILL OCCUR, THE USER SHOULD SIMULTANEOUSLY PRESS THE BUTTONS [TRENDELENBURG], [REVERSE TRENDELENBURG] AND [0-POSITION] ON THE HAND CONTROL OF THE HYBRID OPERATING TABLE. THE INTERFACE SOFTWARE WILL BE SHUT DOWN: THE SYMBOL [HYBRID OPERATING TABLE] SWITCHES TO OR MODE AND WILL BE DEACTIVATED ON THE DISPLAY OF THE HAND CONTROL. AFTER THAT, THE FUNCTIONS NEED TO BE CHECKED. IF THE PROBLEM STILL OCCUR, THE SERVICE SHOULD BE INFORMED. IN THE IFU (IFU 1180.01 EN 33, PAGE 87) THE USER IS INFORMED THAT THE COLUMN MAY BE ROTATED MANUALLY WHICH CAN BE USED IF THE DEVICE WILL BE BLOCKED BY EXTERNAL DEVICE. BASED ON ALL GATHERED INFORMATION IT CAN BE CONCLUDED THAT THE REPORTED ISSUE WAS CAUSED BY THE TECHNICIAN¿S ERROR RELATED TO INCORRECTLY CONDUCTED REPAIR PRIOR TO THE EVENT OCCURRENCE. THE TECHNICIAN WAS REMINDED ABOUT THE IMPORTANCE OF FOLLOWING THE INSTRUCTIONS GIVEN IN THE SERVICE MANUAL. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OF THE DEVICE WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS NOT UP TO THE SPECIFICATION. PERFORMED REVIEW REVEALED NO FURTHER CUSTOMER PRODUCT COMPLAINTS RELATED TO THE ISSUE INVESTIGATED HEREIN, THEREFORE, IT IS CONSIDERED A SINGLE AND ISOLATED CASE. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D3 MANUFACTURER, H6 MEDICAL DEVICE ¿ PROBLEM CODE, H6 COMPONENT CODES FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: THE FOLLOWING WAS REPORTED TO US. THE SIEMENS ANGIOGRAPHY SYSTEM WAS USED WITH 118001B2 HYBRID OR TABLE COLUMN FROM GETINGE - MAQUET. DURING THE SURGERY THE SIEMENS SYSTEM GOT LOCKED AND COULD NOT BE MOVED. THE SIEMENS ANGIOGRAPHY SYSTEM WAS IN THE WAY OF CARDIOPULMONARY RESUSCITATION. IN THE COURSE OF THE SURGERY THE PATIENT HAD A CARDIAC ARREST WHICH RESULTED IN PATIENT'S DEATH. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 19TH APRIL 2022 GETINGE BECAME AWARE OF AN ISSUE WITH 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, GETINGE DEVICE WAS USED WITH SIEMENS ANGIOGRAPHY SYSTEM. DURING THE SURGERY, THE SIEMENS SYSTEM GOT LOCKED AND MAGNUS TABLE OR SIEMENS ANGIOGRAPHY SYSTEM COULD NOT BE MOVED. THE SIEMENS ANGIOGRAPHY SYSTEM WAS IN THE WAY OF CARDIOPULMONARY RESUSCITATION. IN THE COURSE OF THE SURGERY, THE PATIENT HAD A CARDIAC ARREST, WHICH RESULTED IN THE PATIENT'S DEATH. PREVIOUS D3 MANUFACTURER: HOLGER ULLRICH. CORRECTED D3 MANUFACTURER: MAQUET GMBH. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: COMMUNICATION OR TRANSMISSION PROBLEM///2896. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MATERIAL INTEGRITY PROBLEM/DEGRADED//1153. ACTIVATION, POSITIONING OR SEPARATIONPROBLEM/POSITIONING PROBLEM//3009. PREVIOUS H6 COMPONENT CODES: MEASUREMENT/SENSOR//510. MECHANICAL/SEAL//432. ELECTRICAL AND MAGNETIC/CIRCUIT BOARD//427. CORRECTED H6 COMPONENT CODES: MECHANICAL/SEAL//432.
THE FOLLOWING WAS REPORTED TO US. THE SIEMENS ANGIOGRAPHY SYSTEM WAS USED WITH 118001B2 HYBRID OR TABLE COLUMN FROM GETINGE - MAQUET. DURING THE SURGERY THE SIEMENS SYSTEM GOT LOCKED AND COULD NOT BE MOVED. THE SIEMENS ANGIOGRAPHY SYSTEM WAS IN THE WAY OF CARDIOPULMONARY RESUSCITATION. IN THE COURSE OF THE SURGERY THE PATIENT HAD A CARDIAC ARREST WHICH RESULTED IN PATIENT'S DEATH. REF- (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
ON 19TH APRIL 2022 GETINGE BECAME AWARE OF AN ISSUE WITH 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, GETINGE DEVICE WAS USED WITH SIEMENS ANGIOGRAPHY SYSTEM. DURING THE SURGERY, THE SIEMENS SYSTEM GOT LOCKED AND MAGNUS TABLE OR SIEMENS ANGIOGRAPHY SYSTEM COULD NOT BE MOVED. THE SIEMENS ANGIOGRAPHY SYSTEM WAS IN THE WAY OF CARDIOPULMONARY RESUSCITATION. IN THE COURSE OF THE SURGERY, THE PATIENT HAD A CARDIAC ARREST, WHICH RESULTED IN THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 742057 | HYBRID OR TABLE COLUMN, SURFACE-MOUNTED | TABLE, OPERATING-ROOM, AC-POWERED | FQO | HOLGER ULLRICH | 118001B2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Death |