KNEELING FRAME

Additional Manufacturer Narrative

E1 INITIAL REPORTER: (B)(6). THE FULL UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE MALFUNCTION OF THE LOCKING MECHANISM WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS FOUND NO PAST REPORTS OF SIMILAR INCIDENTS RESULTING IN INJURY TO EITHER A PATIENT OR AN OPERATOR. AS A RESULT OF THE CUSTOMER¿S INTERNAL INVESTIGATION, IT WAS CONCLUDED THAT THE FASTENING HOOKS OF THE AFFECTED DEVICE HAD PREVIOUSLY BEEN DAMAGED DUE TO MISUSE. PHOTOGRAPHIC EVIDENCE SHOWED THAT PARTS OF THE HOOKS WERE BENT, PREVENTING PROPER LOCKING BETWEEN THE DEVICE AND THE OPERATING TABLE. IT WAS DETERMINED THAT THE DEFORMATION HAD OCCURRED IN THE PAST AND WAS NOT CAUSED BY THE REPORTED INCIDENT. THERE IS INFORMATION IN THE IFU (GA 1007.04 REV 19, PAGE 35) THAT A DAMAGED PRODUCT MAY NOT BE USED. ADDITIONALLY, THE MALFUNCTION SHOULD HAVE BEEN IDENTIFIED DURING THE PRE-USE CHECK PROCEDURE. THE CUSTOMER HAS BEEN INFORMED IN THE MANUAL THAT VISUAL AND FUNCTIONAL INSPECTIONS MUST BE PERFORMED BY A TRAINED PERSON PRIOR TO EACH USE, WITH AN EXAMPLE OF A FUNCTIONAL INSPECTION CHECKLIST PROVIDED IN THE IFU (GA 1007.04 REV 19, PAGE 34). THE INSTRUCTION FOR USE FOR THE AFFECTED ACCESSORY (GA 1007.04 REV 19, PAGE 16) PROVIDES INFORMATION ON THE CORRECT SETUP FOR ATTACHING THE DEVICE FOR SPINAL SURGERY TO THE OPERATING TABLE. BASED ON ALL AVAILABLE INFORMATION IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR DUE TO INCORRECT MOUNTING OF THE OF THE DEVICE WITH DAMAGED LOCKING POINTS. 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.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER.

Additional Manufacturer Narrative

THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM AND H11 ADDITIONAL MANUFACTURER NARRATIVE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE MALFUNCTION OF THE LOCKING MECHANISM WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE MALFUNCTION OF THE LOCKING MECHANISM WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. PREVIOUS H11 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE MALFUNCTION OF THE LOCKING MECHANISM WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS FOUND NO PAST REPORTS OF SIMILAR INCIDENTS RESULTING IN INJURY TO EITHER A PATIENT OR AN OPERATOR. AS A RESULT OF THE CUSTOMER¿S INTERNAL INVESTIGATION, IT WAS CONCLUDED THAT THE FASTENING HOOKS OF THE AFFECTED DEVICE HAD PREVIOUSLY BEEN DAMAGED DUE TO MISUSE. PHOTOGRAPHIC EVIDENCE SHOWED THAT PARTS OF THE HOOKS WERE BENT, PREVENTING PROPER LOCKING BETWEEN THE DEVICE AND THE OPERATING TABLE. IT WAS DETERMINED THAT THE DEFORMATION HAD OCCURRED IN THE PAST AND WAS NOT CAUSED BY THE REPORTED INCIDENT. THERE IS INFORMATION IN THE IFU (GA 1007.04 REV 19, PAGE 35) THAT A DAMAGED PRODUCT MAY NOT BE USED. ADDITIONALLY, THE MALFUNCTION SHOULD HAVE BEEN IDENTIFIED DURING THE PRE-USE CHECK PROCEDURE. THE CUSTOMER HAS BEEN INFORMED IN THE MANUAL THAT VISUAL AND FUNCTIONAL INSPECTIONS MUST BE PERFORMED BY A TRAINED PERSON PRIOR TO EACH USE, WITH AN EXAMPLE OF A FUNCTIONAL INSPECTION CHECKLIST PROVIDED IN THE IFU (GA 1007.04 REV 19, PAGE 34). THE INSTRUCTION FOR USE FOR THE AFFECTED ACCESSORY (GA 1007.04 REV 19, PAGE 16) PROVIDES INFORMATION ON THE CORRECT SETUP FOR ATTACHING THE DEVICE FOR SPINAL SURGERY TO THE OPERATING TABLE. BASED ON ALL AVAILABLE INFORMATION IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR DUE TO INCORRECT MOUNTING OF THE OF THE DEVICE WITH DAMAGED LOCKING POINTS. 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. CORRECTED H11 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE MALFUNCTION OF THE LOCKING MECHANISM WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS FOUND NO PAST REPORTS OF SIMILAR INCIDENTS RESULTING IN INJURY TO EITHER A PATIENT OR AN OPERATOR. AS A RESULT OF THE CUSTOMER¿S INTERNAL INVESTIGATION, IT WAS CONCLUDED THAT THE FASTENING HOOKS OF THE AFFECTED DEVICE HAD PREVIOUSLY BEEN DAMAGED DUE TO MISUSE. PHOTOGRAPHIC EVIDENCE SHOWED THAT PARTS OF THE HOOKS WERE BENT, PREVENTING PROPER LOCKING BETWEEN THE DEVICE AND THE OPERATING TABLE. IT WAS DETERMINED THAT THE DEFORMATION HAD OCCURRED IN THE PAST AND WAS NOT CAUSED BY THE REPORTED INCIDENT. THERE IS INFORMATION IN THE IFU (GA 1007.04 REV 19, PAGE 35) THAT A DAMAGED PRODUCT MAY NOT BE USED. ADDITIONALLY, THE MALFUNCTION SHOULD HAVE BEEN IDENTIFIED DURING THE PRE-USE CHECK PROCEDURE. THE CUSTOMER HAS BEEN INFORMED IN THE MANUAL THAT VISUAL AND FUNCTIONAL INSPECTIONS MUST BE PERFORMED BY A TRAINED PERSON PRIOR TO EACH USE, WITH AN EXAMPLE OF A FUNCTIONAL INSPECTION CHECKLIST PROVIDED IN THE IFU (GA 1007.04 REV 19, PAGE 34). THE INSTRUCTION FOR USE FOR THE AFFECTED ACCESSORY (GA 1007.04 REV 19, PAGE 16) PROVIDES INFORMATION ON THE CORRECT SETUP FOR ATTACHING THE DEVICE FOR SPINAL SURGERY TO THE OPERATING TABLE. BASED ON ALL AVAILABLE INFORMATION IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR DUE TO INCORRECT MOUNTING OF THE OF THE DEVICE WITH DAMAGED LOCKING POINTS. 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.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP, INDIVIDUAL CONFIGURATION. AS STATED, DURING THE PATIENT¿S TRANSFER FROM THE OPERATING TABLE TO THE BED, THE OR TABLE WAS INTENTIONALLY MOVED BY A NURSE. AS A RESULT, THE FRAME DETACHED FROM ITS HINGE POINTS AND FELL APPROXIMATELY 80 CM ONTO THE NURSE¿S LEFT FOOT AND AGAINST THE LEFT HAND, RESULTING IN A FRACTURE OF THE THIRD TOE AND A SLIGHT BRUISE TO THE HAND. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE USER.