PAIR OF LEG PLATES

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** PREVIOUS D1 BRAND NAME: PAIR OF LEG PLATES, 4-PART. CORRECTED D1 BRAND NAME: PAIR OF LEG PLATES. PREVIOUS D4 CATALOG #: 113373BC. CORRECTED D4 CATALOG #: N/A. PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: MISSING. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS H4 DEVICE MANUFACTURE DATE: N/A. CORRECTED H4 DEVICE MANUFACTURE DATE: 06/29/2023. THE CORRECTION OF H11 ADDITIONAL MANUFACTURER NARRATIVE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H11 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR THE PATIENT¿S TREATMENT, HOWEVER WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THERE IS NO INDICATION THAT THERE WAS ANY MALFUNCTION OF THE PRODUCT, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER, A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF LEG PLATES WITH THE AFOREMENTIONED CATALOG NUMBERS PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,22% AS THERE WERE FOUR SIMILAR REPORTABLE CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF LEG PLATES AND MEERA MOBILE TABLES WITH AFOREMENTIONED CATALOG NUMBERS PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,04% FOR THE ISSUE INVESTIGATED HEREIN. ACCORDING TO THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN, THE AFFECTED LEG PLATES WERE REPLACED WITH A NEW ONE. THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE WAS CONTACTED TO ESTABLISH THE ROOT CAUSE OF THIS ISSUE. THE SME ASSESSED THAT THE DESIGN IMPLEMENTED IN THE AFFECTED LEG PLATES WAS DEVELOPED WITH SECURITY AGAINST UNWANTED RELEASE AND ANY PINCHING RISK COULD NOT BE IDENTIFIED. IN THE USER MANUAL (IFU 1333.73 EN 07, PAGE 11), THE USER IS INFORMED ABOUT DANGED RESULTING FROM IMPROPER HANDLING. THE USER IS ALSO WARNED (IFU 1333.73 EN 07, PAGE 11), THAT WHEN ADJUSTING, MOVING OR STORING OR TABLE/ TABLE TOP, THE STAFF, THE PATIENT AND THE ACCESSORIES ARE EXPOSED TO PINCHING AND SHEARING HAZARDS, PARTICULARLY IN THE AREA AROUND THE JOINTS AT THE HEAD REST, BACK AND LEG PLATES. THE USER SHALL ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS. IT IS LIKELY THAT THE USER UTILIZED THE LEG PLATES DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL. BASED ON ALL AVAILABLE INFORMATION THE SME ESTABLISHED THAT THE ROOT CAUSE FOR THE THREE USERS CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES, WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE, WAS MOST LIKELY RELATED TO THE USER ERROR. 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. CORRECTED H11 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED, THREE USERS CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO THE PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING THE USE OF THE LEG PLATE, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR THE PATIENT¿S TREATMENT, HOWEVER WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THERE IS NO INDICATION THAT THERE WAS ANY MALFUNCTION OF THE PRODUCT, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER, A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF LEG PLATES WITH THE AFOREMENTIONED CATALOG NUMBERS PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,22% AS THERE WERE FOUR SIMILAR REPORTABLE CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF LEG PLATES AND MEERA MOBILE TABLES WITH AFOREMENTIONED CATALOG NUMBERS PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,04% FOR THE ISSUE INVESTIGATED HEREIN. ACCORDING TO THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN, THE AFFECTED LEG PLATES WERE REPLACED WITH A NEW ONE. THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE WAS CONTACTED TO ESTABLISH THE ROOT CAUSE OF THIS ISSUE. THE SME ASSESSED THAT THE DESIGN IMPLEMENTED IN THE AFFECTED LEG PLATES WAS DEVELOPED WITH SECURITY AGAINST UNWANTED RELEASE AND ANY PINCHING RISK COULD NOT BE IDENTIFIED. IN THE USER MANUAL (IFU 1333.73 REV. 08, PAGE 11), THE USER IS INFORMED ABOUT DANGED RESULTING FROM IMPROPER HANDLING. THE USER IS ALSO WARNED (IFU 1333.73 REV. 08, PAGE 11), THAT WHEN ADJUSTING, MOVING OR STORING OR TABLE/ TABLE TOP, THE STAFF, THE PATIENT AND THE ACCESSORIES ARE EXPOSED TO PINCHING AND SHEARING HAZARDS, PARTICULARLY IN THE AREA AROUND THE JOINTS AT THE HEAD REST, BACK AND LEG PLATES. THE USER SHALL ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS. IT IS LIKELY THAT THE USER UTILIZED THE LEG PLATES DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL. BASED ON ALL AVAILABLE INFORMATION THE SME ESTABLISHED THAT THE ROOT CAUSE FOR THE THREE USERS CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES, WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE, WAS MOST LIKELY RELATED TO THE USER ERROR. 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.

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

THE PURPOSE OF THIS SUBMISSION IS SOLELY TO PROVIDE A CORRECTION OF MANUFACTURING DATE. THE CORRECTION OF H4 DEVICE MANUFACTURE DATE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 DEVICE MANUFACTURE DATE: 12/20/2023. CORRECTED H4 DEVICE MANUFACTURE DATE: N/A.

Description of Event or Problem

MANUFACTURER'S REFERENCE NUMBER (B)(4).

Description of Event or Problem

ON 12TH DECEMBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR THE PATIENT¿S TREATMENT, HOWEVER WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THERE IS NO INDICATION THAT THERE WAS ANY MALFUNCTION OF THE PRODUCT, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER, A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. (B)(4). ACCORDING TO THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN, THE AFFECTED LEG PLATES WERE REPLACED WITH A NEW ONE. THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE WAS CONTACTED TO ESTABLISH THE ROOT CAUSE OF THIS ISSUE. THE SME ASSESSED THAT THE DESIGN IMPLEMENTED IN THE AFFECTED LEG PLATES WAS DEVELOPED WITH SECURITY AGAINST UNWANTED RELEASE AND ANY PINCHING RISK COULD NOT BE IDENTIFIED. IN THE USER MANUAL (IFU 1333.73 EN 07, PAGE 11), THE USER IS INFORMED ABOUT DANGLED RESULTING FROM IMPROPER HANDLING. THE USER IS ALSO WARNED (IFU 1333.73 EN 07, PAGE 11), THAT WHEN ADJUSTING, MOVING OR STORING OR TABLE/ TABLE TOP, THE STAFF, THE PATIENT AND THE ACCESSORIES ARE EXPOSED TO PINCHING AND SHEARING HAZARDS, PARTICULARLY IN THE AREA AROUND THE JOINTS AT THE HEAD REST, BACK AND LEG PLATES. THE USER SHALL ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS. IT IS LIKELY THAT THE USER UTILIZED THE LEG PLATES DISREGARDING SAFETY NOTES AND SUGGESTIONS FROM THE USER MANUAL. BASED ON ALL AVAILABLE INFORMATION THE SME ESTABLISHED THAT THE ROOT CAUSE FOR THE THREE USERS CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES, WHILE OPERATING THE RELEASE LEVER OF THE LEG PLATE, WAS MOST LIKELY RELATED TO THE USER ERROR. 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 12TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 12TH DECEMBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, 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 12TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR.