LEG PLATES, PAIR

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 115063DC LEG PLATES, PAIR. ACCORDING TO THE INITIALLY PROVIDED INFORMATION, THE WELD SEAM ON THE LEFT-HAND SIDE OF CONNECTING BLOCK TORE. THE MENTIONED WELD MALFUNCTION WAS DISCOVERED DURING THE TRANSFER OF THE PATIENT AFTER THE PROCEDURE AND LED TO THE DETACHMENT OF THE PART AND ITS FALL. THE PATIENT WAS CONSCIOUS AT THE TIME OF THE INCIDENT. ON 11TH APRIL 2023, IT HAS BEEN CLARIFIED THAT THE DETACHMENT RESULTED IN A SLIGHT CHANGE IN THE PATIENT'S POSITION WHICH WAS CONSIDERED AS A REPORTABLE ISSUE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY LEG SUPPORT DETACHMENT THAT COULD CAUSE A FAST UNINTENDED MOVEMENT OF THE LEG PLATE AND CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR. THE GETINGE TECHNICIAN EXAMINED THE AFFECTED LEG PLATE AND CONFIRMED THE MALFUNCTION. EVENTUALLY, THE PART HAS BEEN SCRAPPED AS A REPAIR OF THE AFFECTED DEVICE WAS NOT POSSIBLE DUE TO A LACK OF SPARE PARTS AS THE PRODUCT HAS BEEN DISCONTINUED FROM PRODUCTION SINCE 2001 AND TECHNICAL SUPPORT ENDED IN 2011. WITH THE INFORMATION GATHERED AS A RESULT OF THE ROOT CAUSE ANALYSIS PERFORMED, WE CONCLUDE THAT THE REPORTED EVENT WAS PROBABLY CAUSED BY LEG PLATE OVERLOADING IN THE COURSE OF PRODUCT LIFE, WHICH COULD HAVE RESULTED IN THE WELD SEAM TEAR AND CONSEQUENTLY LEAD TO PART DETACHMENT. AS THE SERVICE TECHNICIAN IT IS PROBABLE THAT THE USER, ESPECIALLY DURING REPOSITIONING, BRIEFLY SHIFTS ALL OR MOST OF THE PATIENT'S WEIGHT ONTO THE LEG PLATES - THE PATIENT SUPPORTS HIMSELF WITH HIS HANDS OR SLIDE DOWN WITH THE UPPER BODY UPRIGHT. THE LEG PLATES ARE INTENDED TO POSITION PATIENT¿S LEGS (GA 115063 GB 04, PAGE 4). THE USER MANUAL INSTRUCTS TO PLACE ONLY PATIENT¿S LEGS ON THE LEG PLATES. THE MAXIMUM LOAD OF WEIGHT CORRESPONDS TO 25 KG PER LEG PLATE (GA 115063 GB 04, PAGE 4). WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT AND WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. THE ACTUAL MALFUNCTION, NAMELY WELD SEAM BROKE WAS IDENTIFIED AND THEREFORE, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS NOT UP TO SPECIFICATION. THE ROOT CAUSE ESTABLISHED FOR THIS PARTICULAR SITUATION POINTS TO USER ERROR RELATED WITH THE OVERLOADING OF THE PART WHICH IS NOT IN LINE 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 DUE TO THE UPDATE OF THE AWARE DATE. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 23RD NOVEMBER 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 115063DC LEG PLATES, PAIR. AS IT WAS INITIALLY STATED, THE WELD SEAM ON THE LEFT-HAND SIDE OF CONNECTING BLOCK TORE. LATER ON IT HAS BEEN CLARIFIED THAT THE MENTIONED WELD MALFUNCTION WAS DISCOVERED DURING TRANSFER OF THE PATIENT AFTER THE PROCEDURE AND LED TO THE DETACHMENT OF THE PART AND ITS FALL. CONSEQUENTLY, THE DETACHMENT RESULTED IN SLIGHT CHANGE IN THE PATIENT POSITION. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT WAS CONSCIOUS AT THE TIME OF INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY LEG SUPPORT DETACHMENT THAT COULD CAUSE A FAST UNINTENDED MOVEMENT OF LEG PLATE AND CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 23RD NOVEMBER 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 115063DC LEG PLATES, PAIR. ACCORDING TO THE INITIALLY PROVIDED INFORMATION, THE WELD SEAM ON THE LEFT-HAND SIDE OF CONNECTING BLOCK TORE. THE MENTIONED WELD MALFUNCTION WAS DISCOVERED DURING THE TRANSFER OF THE PATIENT AFTER THE PROCEDURE AND LED TO THE DETACHMENT OF THE PART AND ITS FALL. THE PATIENT WAS CONSCIOUS AT THE TIME OF THE INCIDENT. ON 11TH APRIL 2023, IT HAS BEEN CLARIFIED THAT THE DETACHMENT OF THE PART RESULTED IN A SLIGHT CHANGE IN THE PATIENT'S POSITION WHICH WAS CONSIDERED AS A SITUATION THAT COULD POTENTIALLY LEAD TO ADVERSE OUTCOME. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY LEG SUPPORT DETACHMENT THAT COULD CAUSE A FAST UNINTENDED MOVEMENT OF THE LEG PLATE AND CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

Description of Event or Problem

ON 23RD NOVEMBER 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 115063DC LEG PLATES, PAIR. ACCORDING TO THE INITIALLY PROVIDED INFORMATION, THE WELD SEAM ON THE LEFT-HAND SIDE OF CONNECTING BLOCK TORE. THE MENTIONED WELD MALFUNCTION WAS DISCOVERED DURING THE TRANSFER OF THE PATIENT AFTER THE PROCEDURE AND LED TO THE DETACHMENT OF THE PART AND ITS FALL. THE PATIENT WAS CONSCIOUS AT THE TIME OF THE INCIDENT. ON 11TH APRIL 2023, IT HAS BEEN CLARIFIED THAT THE DETACHMENT OF THE PART RESULTED IN A SLIGHT CHANGE IN THE PATIENT'S POSITION WHICH WAS CONSIDERED AS A SITUATION THAT COULD POTENTIALLY LEAD TO ADVERSE OUTCOME. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY LEG SUPPORT DETACHMENT THAT COULD CAUSE A FAST UNINTENDED MOVEMENT OF THE LEG PLATE AND CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 115063DC LEG PLATES, PAIR. AS IT WAS INITIALLY STATED, THE WELD SEAM ON THE LEFT-HAND SIDE OF CONNECTING BLOCK TORE. LATER ON IT HAS BEEN CLARIFIED THAT THE MENTIONED WELD MALFUNCTION WAS DISCOVERED DURING TRANSFER OF THE PATIENT AFTER THE PROCEDURE AND LED TO THE DETACHMENT OF THE PART AND ITS FALL. CONSEQUENTLY, THE DETACHMENT RESULTED IN SLIGHT CHANGE IN THE PATIENT POSITION. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT WAS CONSCIOUS AT THE TIME OF INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY LEG SUPPORT DETACHMENT THAT COULD CAUSE A FAST UNINTENDED MOVEMENT OF LEG PLATE AND CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.