HEAD REST

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES 100286B0 HEAD REST USED WITH 114020AN - EXTENSIONS TABLE TOP. AS IT WAS STATED, THE HEAD PART OF THE EXTENSION TABLE BROKE OFF AT THE WELD SEAM DURING THE ONGOING SURGERY WITH A PATIENT ON THE OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE HEAD PART WHILE THE PATIENT WAS ON THE OPERATING TABLE, WHICH COULD RESULT IN THE NERVE OVERSTRETCHING, 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 OCCURRED, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR TO A PATIENT OR AN OPERATOR WHEN THIS PARTICULAR ISSUE OCCURRED. THE AFFECTED DEVICE WAS NOT EVALUATED BY THE GETINGE TECHNICIAN. THE CUSTOMER'S ALLEGATION WAS CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE. THE RETURN OF THE AFFECTED DEVICE WAS REQUESTED BY THE MANUFACTURER. UNFORTUNATELY, THE CUSTOMER DID NOT RESPOND, MAKING THE RETURN IMPOSSIBLE. THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE WAS CONTACTED TO ASSESS THE MOST PROBABLE ROOT CAUSE OF THE ISSUE. BASED ON THE PROVIDED ASSESSMENT, ONE OF THE POSSIBLE ROOT CAUSES COULD BE WEAR AND TEAR. HOWEVER, SINCE THE SERIAL NUMBER OF THE AFFECTED DEVICE WAS NOT PROVIDED, AND THE AFFECTED DEVICE COULD NOT BE RETURNED FOR FURTHER ANALYSIS, IT WAS DETERMINED THAT THE EXACT CAUSE OF THE DESCRIBED EVENT COULD NOT BE IDENTIFIED. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT THE INVESTIGATED ISSUE, NAMELY THE DETACHMENT OF THE HEAD PART WHILE THE PATIENT WAS ON THE OPERATING TABLE, WHICH COULD RESULT IN THE NERVE OVERSTRETCHING, WAS IMPOSSIBLE TO DEFINE. 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. THE MANUFACTURING DATE IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED. THE CORRECTION OF D9 DEVICE AVAILABLE FOR EVALUATION, H3B DEVICE NOT EVAL PROVIDE CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D9 DEVICE AVAILABLE FOR EVALUATION: YES. CORRECTED D9 DEVICE AVAILABLE FOR EVALUATION: NO. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: OTHER.

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. THE FULL UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES 100286B0 HEAD REST USED WITH 114020AN - EXTENSIONS TABLE TOP. AS IT WAS STATED, THE HEAD PART OF THE EXTENSION TABLE BROKE OFF AT THE WELD SEAM DURING THE ONGOING SURGERY WITH A PATIENT ON THE OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE HEAD PART WHILE THE PATIENT WAS ON THE OPERATING TABLE WHICH COULD RESULT IN THE NERVE OVERSTRECHING, WAS TO REOCCUR.