HEAD REST, DOUBLE ARTICULATION, SFC, EU

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116053BC HEAD REST, DOUBLE ARTICULATION SFC EU USED WITH 116032BC EXTENSION PLATE SFC PAD EU, 116010B0 UNIVERSAL TABLE TOP SFC EU AND 116001D0 OR TABLE COLUMN MANOEUVRABLE DURING MIS OPERATION. AS IT WAS STATED, DURING POSITIONING OF THE PATIENT INTO TRENDELENBURG VIA REMOTE CONTROL, THE ANESTHESIA BAR FROM THE OPERATING TABLE BECAME WEDGED IN THE CHASSIS OF THE ANESTHESIA MACHINE AND TILTED IN SUCH A WAY THAT THE HEAD SECTION OF THE OPERATING TABLE WAS LEVERED OUT. AS A RESULT, THE HEAD SECTION OF THE OPERATING TABLE LOWERED AND THE PATIENT'S NECK HYPEREXTENDED. SINCE THE BEGINNING OF THE OPERATION, THE HEAD WAS ADDITIONALLY SUPPORTED ON A SEPARATE SUPPORT PILLOW TO ENSURE THE PATIENT'S HEAD HAD A STABLE SUPPORT EVEN AT THE TIME WHEN THE HEAD PLATE WAS REMOVED. THE PATIENT'S POSITIONING INCLUDING VENTILATION TUBE AND VITAL PAREMETERS WERE IMMEDIATELY CHECKED. NO ABNORMALITIES WERE FOUND AND THE PROCEDURE WAS PERFORMED AS PLANNED. AFTER THE OPERATION, THE PATIENT WAS WOKEN UP IN A CONTROLLED AND FIXED POSITION AND ADDITIONAL EXAMINATION WAS PERFORMED INCLUDING CHECKING REFLEXES, MOVEMENT, BREATHING AND SWELLING. THE PATIENT WAS MONITORED AT ALL TIMES AND WAS SUBSEQUENTLY TRANSFERRED TO THE NEUROSURGERY DEPARTMENT OF ANOTHER HOSPITAL FOR PREVENTIVE ASSESSMENT. IT HAS BEEN CONCLUDED THERE WAS NO TRAUMA SEQUELAE - NO RESTRICTIONS IN MOBILIZATION OF THE CERVICAL SPINE AND HEAD AND THE PATIENT RETURNED TO THE PRIMARY HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6), 2023 WITHOUT ANY IMPAIRMENTS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE NECK OVERSTRETCHING DUE TO COLLISION OF THE ACCESSORIES LEADING TO LEVERING OUT OF HEAD PLATE, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1 EVENT SITE NAME: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

ON 24TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116053BC HEAD REST, DOUBLE ARTICULATION SFC EU USED WITH OTHER GETINGE DEVICES: 116032BC EXTENSION PLATE SFC PAD EU, 116010B0 UNIVERSAL TABLE TOP SFC EU AND116001D0 OR TABLE COLUMN MANOEUVRABLE, TRUMPF ANESTHESIA BAR 1218804 AND UNSPECIFIED ANESTHETIC MACHINE DURING MIS OPERATION. AS IT WAS STATED, ON (B)(6) 2023, DURING THE POSITIONING OF THE PATIENT INTO TRENDELENBURG VIA REMOTE CONTROL, THE ANESTHESIA BAR FROM THE OPERATING TABLE BECAME WEDGED IN THE CHASSIS OF THE ANESTHESIA MACHINE AND TILTED IN SUCH A WAY THAT THE HEAD SECTION OF THE OPERATING TABLE WAS LEVERED OUT. FURTHER IT HAS BEEN REVEALED THAT A COLLISION CAUSED THE TENSION ALSO IN THE BACK PLATE. AS A RESULT, THE HEAD SECTION OF THE OPERATING TABLE LOWERED AND THE PATIENT'S NECK HYPEREXTENDED. SINCE THE BEGINNING OF THE OPERATION, THE HEAD WAS ADDITIONALLY SUPPORTED ON A SEPARATE SUPPORT PILLOW TO ENSURE THE PATIENT'S HEAD HAD STABLE SUPPORT EVEN AT THE TIME WHEN THE HEAD PLATE WAS REMOVED. THE PATIENT'S POSITIONING INCLUDING THE VENTILATION TUBE AND VITAL PARAMETERS WERE IMMEDIATELY CHECKED. NO ABNORMALITIES WERE FOUND AND THE PROCEDURE WAS PERFORMED AS PLANNED. AFTER THE OPERATION, THE PATIENT WAS WOKEN UP IN A CONTROLLED AND FIXED POSITION AND AN ADDITIONAL EXAMINATION WAS PERFORMED INCLUDING CHECKING REFLEXES, MOVEMENT, BREATHING AND SWELLING. THE PATIENT WAS MONITORED AT ALL TIMES AND WAS SUBSEQUENTLY TRANSFERRED TO THE NEUROSURGERY DEPARTMENT OF ANOTHER HOSPITAL FOR PREVENTIVE ASSESSMENT. IT HAS BEEN CONCLUDED THERE WAS NO TRAUMA SEQUELAE - NO RESTRICTIONS IN MOBILIZATION OF THE CERVICAL SPINE AND HEAD AND THE PATIENT RETURNED TO THE PRIMARY HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6), 2023 WITHOUT ANY IMPAIRMENTS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE COLLISION OF THE ACCESSORIES LEADING TO LEVERING OUT OF HEAD PLATE AND CAUSING THE NECK OVERSTRETCHING, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICES WERE BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WERE ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE HEAD REST AND EXTENSION PLATE MALFUNCTIONS WERE FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICES WERE NOT UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE ISSUE INVESTIGATED HEREIN IS 0,06% FOR THE 116053 HEADRESTS AND 0,02% FOR CONFIGURATION OF 116053 HEAD REST AND 116032 EXTENSION PLATE AS THERE WAS ONE SIMILAR CUSTOMER PRODUCT COMPLAINT. THE AFFECTED GETINGE DEVICES HAVE BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN. THE TECHNICIAN CONFIRMED THE MALFUNCTION OF THE HEAD REST. THE HEAD REST PLATE WAS BROKEN. THE PLATE WAS REPLACED. THERE WAS NO ISSUE WITH THE TABLE TOP AND COLUMN. IN THE PICTURE ATTACHED TO THE COMPLAINT RECORD BY THE TECHNICIAN, COLLISION MARK CAN BE SEEN ON THE 116032BC EXTENSION PLATE. THE CUSTOMER WAS INSTRUCTED ABOUT THE CORRECT USE OF THE DEVICES IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE TO AVOID THE REOCCURRENCE IN THE FUTURE. IN THE INSTRUCTIONS FOR USE THE HEAD REST (IFU 116053 EN 06, PAGE 11), THE USER IS WARNED ABOUT DANGER RESULTING FROM IMPROPER HANDLING. THE USER SHALL ALWAYS OBSERVE THE INSTRUCTIONS FOR USE. THE USER IS ALSO WARNED (IFU 116053 EN 06, PAGE 11), THAT WHEN THE O.R. TABLE, THE TABLE TOP, OR A PIECE OF ACCESSORIES ARE MOVED OR ADJUSTED, COLLISIONS WITH THE PATIENT, WITH THE INVOLVED PRODUCTS, OR DOWNWARD POSITIONED PARTS MAY OCCUR. DURING THE MOVEMENT THE USER SHALL ALWAYS WATCH THE O.R. TABLE, THE TABLE TOP, AND THE ACCESSORIES TO AVOID COLLISIONS. IN THE IFU (IFU 116053 EN 06, PAGE 11), THE USER IS INFORMED THAT ADDITIONAL ACCESSORIES MOUNTED TO THE SIDE RAILS ARE NOT RECOGNIZED BY OR TABLES/TABLE TOPS RECOGNITION FUNCTION AND MAY LIMIT THE ADJUSTMENT RANGE. IT IS EVIDENT THAT THE USER UTILIZED THE ACCESSORY DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL THEREFORE THE REPORTED ISSUE WAS CAUSED BY USER ERROR AND NON-COMPLIANCE WITH THE USER MANUAL. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE 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. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 24TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116053BC HEAD REST, DOUBLE ARTICULATION SFC EU USED WITH 116032BC EXTENSION PLATE SFC PAD EU, 116010B0 UNIVERSAL TABLE TOP SFC EU AND 116001D0 OR TABLE COLUMN MANOEUVRABLE DURING MIS OPERATION. AS IT WAS STATED, DURING POSITIONING OF THE PATIENT INTO TRENDELENBURG VIA REMOTE CONTROL, THE ANESTHESIA BAR FROM THE OPERATING TABLE BECAME WEDGED IN THE CHASSIS OF THE ANESTHESIA MACHINE AND TILTED IN SUCH A WAY THAT THE HEAD SECTION OF THE OPERATING TABLE WAS LEVERED OUT. AS A RESULT, THE HEAD SECTION OF THE OPERATING TABLE LOWERED AND THE PATIENT'S NECK HYPEREXTENDED. SINCE THE BEGINNING OF THE OPERATION, THE HEAD WAS ADDITIONALLY SUPPORTED ON A SEPARATE SUPPORT PILLOW TO ENSURE THE PATIENT'S HEAD HAD A STABLE SUPPORT EVEN AT THE TIME WHEN THE HEAD PLATE WAS REMOVED. THE PATIENT'S POSITIONING INCLUDING VENTILATION TUBE AND VITAL PAREMETERS WERE IMMEDIATELY CHECKED. NO ABNORMALITIES WERE FOUND AND THE PROCEDURE WAS PERFORMED AS PLANNED. AFTER THE OPERATION, THE PATIENT WAS WOKEN UP IN A CONTROLLED AND FIXED POSITION AND ADDITIONAL EXAMINATION WAS PERFORMED INCLUDING CHECKING REFLEXES, MOVEMENT, BREATHING AND SWELLING. THE PATIENT WAS MONITORED AT ALL TIMES AND WAS SUBSEQUENTLY TRANSFERRED TO THE NEUROSURGERY DEPARTMENT OF ANOTHER HOSPITAL FOR PREVENTIVE ASSESSMENT. IT HAS BEEN CONCLUDED THERE WAS NO TRAUMA SEQUELAE - NO RESTRICTIONS IN MOBILIZATION OF THE CERVICAL SPINE AND HEAD AND THE PATIENT RETURNED TO THE PRIMARY HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT ANY IMPAIRMENTS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE NECK OVERSTRETCHING DUE TO COLLISION OF THE ACCESSORIES LEADING TO LEVERING OUT OF HEAD PLATE, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 24TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116053BC HEAD REST, DOUBLE ARTICULATION SFC EU USED WITH OTHER GETINGE DEVICES: 116032BC EXTENSION PLATE SFC PAD EU, 116010B0 UNIVERSAL TABLE TOP SFC EU AND116001D0 OR TABLE COLUMN MANOEUVRABLE, TRUMPF ANESTHESIA BAR 1218804 AND UNSPECIFIED ANESTHETIC MACHINE DURING MIS OPERATION. AS IT WAS STATED, ON (B)(6) 2023, DURING THE POSITIONING OF THE PATIENT INTO TRENDELENBURG VIA REMOTE CONTROL, THE ANESTHESIA BAR FROM THE OPERATING TABLE BECAME WEDGED IN THE CHASSIS OF THE ANESTHESIA MACHINE AND TILTED IN SUCH A WAY THAT THE HEAD SECTION OF THE OPERATING TABLE WAS LEVERED OUT. FURTHER, IT HAS BEEN REVEALED THAT A COLLISION CAUSED THE TENSION ALSO IN THE BACK PLATE. AS A RESULT, THE HEAD SECTION OF THE OPERATING TABLE LOWERED AND THE PATIENT'S NECK HYPEREXTENDED. SINCE THE BEGINNING OF THE OPERATION, THE HEAD WAS ADDITIONALLY SUPPORTED ON A SEPARATE SUPPORT PILLOW TO ENSURE THE PATIENT'S HEAD HAD STABLE SUPPORT EVEN AT THE TIME WHEN THE HEAD PLATE WAS REMOVED. THE PATIENT'S POSITIONING INCLUDING THE VENTILATION TUBE AND VITAL PARAMETERS WERE IMMEDIATELY CHECKED. NO ABNORMALITIES WERE FOUND AND THE PROCEDURE WAS PERFORMED AS PLANNED. AFTER THE OPERATION, THE PATIENT WAS WOKEN UP IN A CONTROLLED AND FIXED POSITION AND AN ADDITIONAL EXAMINATION WAS PERFORMED INCLUDING CHECKING REFLEXES, MOVEMENT, BREATHING AND SWELLING. THE PATIENT WAS MONITORED AT ALL TIMES AND WAS SUBSEQUENTLY TRANSFERRED TO THE NEUROSURGERY DEPARTMENT OF ANOTHER HOSPITAL FOR PREVENTIVE ASSESSMENT. IT HAS BEEN CONCLUDED THERE WAS NO TRAUMA SEQUELAE - NO RESTRICTIONS IN MOBILIZATION OF THE CERVICAL SPINE AND HEAD AND THE PATIENT RETURNED TO THE PRIMARY HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT ANY IMPAIRMENTS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE COLLISION OF THE ACCESSORIES LEADING TO LEVERING OUT OF HEAD PLATE AND CAUSING THE NECK OVERSTRETCHING, WAS TO REOCCUR.

Description of Event or Problem

ON 24TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116053BC HEAD REST, DOUBLE ARTICULATION SFC EU USED WITH OTHER GETINGE DEVICES: 116032BC EXTENSION PLATE SFC PAD EU, 116010B0 UNIVERSAL TABLE TOP SFC EU AND116001D0 OR TABLE COLUMN MANOEUVRABLE, TRUMPF ANESTHESIA BAR 1218804 AND UNSPECIFIED ANESTHETIC MACHINE DURING MIS OPERATION. AS IT WAS STATED, ON (B)(6) 2023, DURING THE POSITIONING OF THE PATIENT INTO TRENDELENBURG VIA REMOTE CONTROL, THE ANESTHESIA BAR FROM THE OPERATING TABLE BECAME WEDGED IN THE CHASSIS OF THE ANESTHESIA MACHINE AND TILTED IN SUCH A WAY THAT THE HEAD SECTION OF THE OPERATING TABLE WAS LEVERED OUT. FURTHER, IT HAS BEEN REVEALED THAT A COLLISION CAUSED THE TENSION ALSO IN THE BACK PLATE. AS A RESULT, THE HEAD SECTION OF THE OPERATING TABLE LOWERED AND THE PATIENT'S NECK HYPEREXTENDED. SINCE THE BEGINNING OF THE OPERATION, THE HEAD WAS ADDITIONALLY SUPPORTED ON A SEPARATE SUPPORT PILLOW TO ENSURE THE PATIENT'S HEAD HAD STABLE SUPPORT EVEN AT THE TIME WHEN THE HEAD PLATE WAS REMOVED. THE PATIENT'S POSITIONING INCLUDING THE VENTILATION TUBE AND VITAL PARAMETERS WERE IMMEDIATELY CHECKED. NO ABNORMALITIES WERE FOUND AND THE PROCEDURE WAS PERFORMED AS PLANNED. AFTER THE OPERATION, THE PATIENT WAS WOKEN UP IN A CONTROLLED AND FIXED POSITION AND AN ADDITIONAL EXAMINATION WAS PERFORMED INCLUDING CHECKING REFLEXES, MOVEMENT, BREATHING AND SWELLING. THE PATIENT WAS MONITORED AT ALL TIMES AND WAS SUBSEQUENTLY TRANSFERRED TO THE NEUROSURGERY DEPARTMENT OF ANOTHER HOSPITAL FOR PREVENTIVE ASSESSMENT. IT HAS BEEN CONCLUDED THERE WAS NO TRAUMA SEQUELAE - NO RESTRICTIONS IN MOBILIZATION OF THE CERVICAL SPINE AND HEAD AND THE PATIENT RETURNED TO THE PRIMARY HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT ANY IMPAIRMENTS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE COLLISION OF THE ACCESSORIES LEADING TO LEVERING OUT OF HEAD PLATE AND CAUSING THE NECK OVERSTRETCHING, WAS TO REOCCUR.