SEAT PLATE EXTENSION

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1B EVENT SITE NAME: DR. (B)(6) H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 31ST JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116055DC - SEAT PLATE EXTENSION, IPC, EU, WASHABLE USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, POSITIONING OF THE PATIENT OVER THE EDGE RESULTED IN PRESSURE ULCER WITH BLISTER FORMATION. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116055DC - SEAT PLATE EXTENSION, IPC, EU, WASHABLE USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, POSITIONING OF THE PATIENT OVER THE EDGE RESULTED IN PRESSURE ULCER WITH BLISTER FORMATION. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS IT WAS CONFIRMED THAT THE ISSUE WAS CAUSED BY THE INAPPROPRIATE PATIENT POSITIONING, IT WAS CONSIDERED THAT THE GETINGE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE SERIOUS INJURIES OF THE PATIENT WHEN THIS PARTICULAR SITUATION OCCURRED. COMPARING THE NUMBER OF DEVICES INVOLVED IN THE ADVERSE EVENT TO THE NUMBER OF 116055 SEAT PLATE EXTENSION ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4) FOR THE ISSUE INVESTIGATED HEREIN. REGARDING THE CONFIGURATION OF BOTH DEVICES, COMPARING THE NUMBER OF DEVICES INVOLVED IN THE ADVERSE EVENT TO THE NUMBER OF 116055 SEAT PLATE EXTENSION AND MEERA MOBILE TABLES ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4) FOR THE ISSUE INVESTIGATED HEREIN. THE COMPLAINT INVESTIGATED HEREIN IS THE SECOND ONE REGISTERED ON THE SAME CUSTOMER WHERE THE SERIOUS INJURY OF THE PATIENT WAS REPORTED. DURING THE VISIT RELATED TO A PREVIOUS CUSTOMER PRODUCT COMPLAINT (MANUFACTURER'S REFERENCE NUMBER: OT 965348, REPORT NUMBER: 8010652-2024-00011) IT WAS ASSESSED THAT THE POSITIONING OF THE PATIENT WAS NOT PERFORMED CORRECTLY. ACCORDING TO THE TECHNICIAN, THE PATIENT WAS POSITIONED OVER THE EDGE OF THE OPERATING TABLE AND LAY WITH HIS BUTTOCKS PARTIALLY EXPOSED ON THE EDGE AND IN THE AIR. THE TECHNICIAN PROVIDED INFORMATION THAT DESPITE THE REPEATED RECOMMENDATIONS, THE CUSTOMER POSITIONED THE PATIENTS IN THE SAME WAY. IN THE USER MANUAL (IFU 1160.55 REV. 08, PAGE 7), THE USER IS INFORMED ABOUT THE RISK POSED TO THE PATIENT'S VITAL FUNCTIONS DUE TO INCORRECT POSITIONING. THE USER IS INSTRUCTED TO POSITION THE PATIENT CORRECTLY AND KEEP UNDER PERMANENT OBSERVATION. MOREOVER, THE USER IS ALSO INFORMED THAT IMPROPER PATIENT POSITIONING MAY CAUSE HEALTH DAMAGE (E. G. DECUBITUS). IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE MOST POSSIBLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE PATIENT SUFFERED THE PRESSURE ULCER WITH BLISTER FORMATION CONSTITUTES A SERIOUS INJURY, IS 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 FULL UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED. THE CORRECTION OF B1 ADVERSE EVENT / PRODUCT PROBLEM, D1 BRAND NAME, D4 CATALOG #, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT & PRODUCT PROBLEM. CORRECTED B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT. PREVIOUS D1 BRAND NAME: SEAT PLATE EXTENSION, IPC, EU, WASHABLE. CORRECTED D1 BRAND NAME: SEAT PLATE EXTENSION. PREVIOUS D4 CATALOG #: 116055DC. CORRECTED D4 CATALOG #: N/A. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A.

Description of Event or Problem

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