HEAD REST

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100286B0 - HEAD REST. AS IT WAS STATED, THE FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FATIGUE FRACTURE OF THE HEAD REST DURING PATIENT POSITIONING, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD, WAS TO REOCCUR. 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 THE MALFUNCTIONS OF THE HEAD REST COULD NOT BE CONFIRMED AS THE CUSTOMER SCRAPPED THE DEVICE, IT WAS ASSUMED THAT THE GETINGE DEVICE WAS NOT UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. THE ISSUE INVESTIGATED HEREIN IS A SINGLE AND ISOLATED CASE. THE GETINGE TECHNICIAN VISITED THE CUSTOMER SITE TO PERFORM AN EVALUATION OF THE AFFECTED DEVICE. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, INQUIRIES TO STAFF WERE UNSUCCESSFUL AND FAULT OF THE ISSUE COULD NOT BE DETERMINED. MOREOVER, THE TECHNICIAN EMPHASIZED THAT THE MANUFACTURE DATE IS UNKNOWN AS THE DEVICE WAS NOT SERIALIZED. FURTHER INFORMATION PROVIDED BY THE TECHNICIAN REVEALED THAT THE FAULT OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE CUSTOMER SCRAPPED THE DEVICE. THE 100286B0 - HEAD REST WAS DISCONTINUED FROM PRODUCTION IN (B)(6) 2020, THEREFORE, IT IS POSSIBLE THAT THE MALFUNCTION OF THE DEVICE COULD BE RELATED TO THE AGE OF THE DEVICE AS THE DEVICE WAS AT LEAST 3 YEARS IN USE. HOWEVER, AS THE DEVICE WAS SCRAPPED, IT WAS NOT POSSIBLE TO PERFORM AN EVALUATION AND ROOT CAUSE ANALYSIS. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD REMAINED IMPOSSIBLE TO DEFINE. 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 CORRECTION OF H10 ADDITIONAL MANUFACTURER NARRATIVE FIELD DEEMS REQUIRED. THIS IS BASED ON THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS H10 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100286B0 - HEAD REST. AS IT WAS STATED, THE FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FATIGUE FRACTURE OF THE HEAD REST DURING PATIENT POSITIONING, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD, WAS TO REOCCUR. 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 THE MALFUNCTIONS OF THE HEAD REST COULD NOT BE CONFIRMED AS THE CUSTOMER SCRAPPED THE DEVICE, IT WAS ASSUMED THAT THE GETINGE DEVICE WAS NOT UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. THE ISSUE INVESTIGATED HEREIN IS A SINGLE AND ISOLATED CASE. THE GETINGE TECHNICIAN VISITED THE CUSTOMER SITE TO PERFORM AN EVALUATION OF THE AFFECTED DEVICE. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, INQUIRIES TO STAFF WERE UNSUCCESSFUL AND FAULT OF THE ISSUE COULD NOT BE DETERMINED. MOREOVER, THE TECHNICIAN EMPHASIZED THAT THE MANUFACTURE DATE IS UNKNOWN AS THE DEVICE WAS NOT SERIALIZED. FURTHER INFORMATION PROVIDED BY THE TECHNICIAN REVEALED THAT THE FAULT OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE CUSTOMER SCRAPPED THE DEVICE. THE 100286B0 - HEAD REST WAS DISCONTINUED FROM PRODUCTION IN (B)(6) 2020, THEREFORE, IT IS POSSIBLE THAT THE MALFUNCTION OF THE DEVICE COULD BE RELATED TO THE AGE OF THE DEVICE AS THE DEVICE WAS AT LEAST 3 YEARS IN USE. HOWEVER, AS THE DEVICE WAS SCRAPPED, IT WAS NOT POSSIBLE TO PERFORM AN EVALUATION AND ROOT CAUSE ANALYSIS. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD REMAINED IMPOSSIBLE TO DEFINE. 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 H10 ADDITIONAL MANUFACTURER NARRATIVE: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100286B0 - HEAD REST. AS IT WAS STATED, THE FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FATIGUE FRACTURE OF THE HEAD REST DURING PATIENT POSITIONING, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD, WAS TO REOCCUR. 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 THE MALFUNCTION OF THE HEAD REST WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE, IT WAS CONCLUDED THAT THE GETINGE DEVICE FAILED TO MEET THE SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. THE ISSUE INVESTIGATED HEREIN IS A SINGLE AND ISOLATED CASE. THE GETINGE TECHNICIAN VISITED THE CUSTOMER SITE TO PERFORM AN EVALUATION OF THE AFFECTED DEVICE. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, INQUIRIES TO STAFF WERE UNSUCCESSFUL AND FAULT OF THE ISSUE COULD NOT BE DETERMINED. MOREOVER, THE TECHNICIAN EMPHASIZED THAT THE MANUFACTURE DATE IS UNKNOWN AS THE DEVICE WAS NOT SERIALIZED. THE TECHNICIAN PROVIDED PHOTOGRAPHIC EVIDENCE OF THE AFFECTED DEVICE. FURTHER RESEARCH PERFORMED BY THE MANUFACTURER REVEALED THAT THE AFFECTED PRODUCT WAS PRODUCED AT LEAST 30 YEARS AGO. PICTURES OF THE AFFECTED PRODUCT SHOW SCRATCHES AND IMPACT MARKS ON THE PRODUCT. BESIDES THE AGE-RELATED FATIGUE MENTIONED BY THE CUSTOMER, ROUGH HANDLING, DROPS AND COLLISIONS CAN ALSO LEAD TO PREVIOUS DAMAGE THAT CONTRIBUTED TO THE FAILURE. IN THE USER MANUAL (IFU 1002.86 EN 09, PAGE 11) THE USER IS WARNED THAT WHEN THE OR TABLE, THE TRANSPORTER, THE TABLE TOP, OR A PIECE OF ACCESSORIES ARE MOVED OR ADJUSTED AS WELL AS DURING THE TAKE-OVER PROCEDURE OF THE TABLE TOP, COLLISIONS WITH THE INVOLVED PRODUCTS, OR DOWNWARD POSITIONED PARTS MAY OCCUR. DURING THE MOVEMENT THE USER SHALL ALWAYS WATCH THE OR TABLE, THE TRANSPORTER, THE TABLE TOP, AND THE ACCESSORIES TO AVOID COLLISIONS. MOREOVER, THE USER IS INFORMED THAT TO ENSURE CORRECT OPERATION, IT IS NECESSARY TO HAVE VISUAL AND FUNCTIONAL INSPECTIONS PERFORMED BY A TRAINED PERSON PRIOR TO EACH USE (IFU 1002.86 EN 09, PAGE 23). THE USER MANUAL ALSO WARNS THAT FAULTY OR DEFECTIVE PRODUCTS MAY RESULT IN INJURIES. BEFORE USE, THE USER SHOULD CHECK THE PROPER WORKING ORDER AND FULLY FUNCTIONAL STATE OF THE PRODUCT. IF ANY MALFUNCTIONS WERE DETECTED, THE USER SHOULD STOP USING FAULTY OR DEFECTIVE PRODUCTS AND INFORM THE GETINGE REPRESENTATIVE (IFU 1002.86 EN 09, PAGE 11). HOWEVER, AS THE DEVICE WAS SCRAPPED, IT WAS NOT POSSIBLE TO PERFORM AN EVALUATION AND CONFIRM ANY ROOT CAUSE. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD REMAINED IMPOSSIBLE TO DEFINE. IT IS WORTH MENTIONING THAT, ACCORDING TO THE USER MANUAL, IT IS NECESSARY TO PERFORM A PRE-USE CHECK TO DETECT ANY DEFECTS OF THE DEVICE AND MINIMIZE RISKS TO THE PATIENT. 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

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. (B)(6).

Description of Event or Problem

ON 13TH SEPTEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100286B0 - HEAD REST. AS IT WAS STATED, THE FATIGUE FRACTURE IN THE HEAD REST RETAINER DURING THE POSITIONING OF THE PATIENT OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY FATIGUE FRACTURE OF THE HEAD REST DURING PATIENT POSITIONING, WHICH COULD LEAD TO FAST UNINTENDED MOVEMENT CAUSING A CHANGE IN THE POSITION OF THE PATIENT'S HEAD, WAS TO REOCCUR.