MAGNUS CARBON FIBRE TABLE TOP

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. D10 CONCOMITANT PRODUCTS: 118001B4 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED E1 EVENT SITE NAME: (B)(6).

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS¿ 118016A2 ¿MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS USED WITH 118001B4 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS REPORTED, DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION PROCEDURE, WHILE THE PATIENT WAS UNDER EMERGENCY GENERAL ANESTHESIA, A MALFUNCTION OCCURRED WITH THE TABLE TOP. ERROR 174 (POSITION ERROR) WAS DISPLAYED ON THE REMOTE CONTROL. DESPITE INTERVENTION BY THE ON-SITE ENGINEERING STAFF, THE DEVICE FAILED TO FUNCTION PROPERLY, AND THE OPERATION COULD NOT CONTINUE. AS A RESULT, THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER OPERATING ROOM TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY, DISRUPTION IN THE EMERGENCY SURGICAL PROCEDURE, WAS TO REOCCUR.

Additional Manufacturer Narrative

THE AFFECTED DEVICE WAS TESTED BY A GETINGE TECHNICIAN. ON-SITE DIAGNOSIS REVEALED A FAULTY BED POTENTIOMETER (PART. NO 2310884 POTENTIOMETER), REQUIRING REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE WAS RETURNED TO SERVICE. BASED ON THE INVESTIGATION CONDUCTED, IT WAS CONCLUDED THAT AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY BEING USED FOR THE PATIENT¿S TREATMENT AND WAS THEREFORE DIRECTLY INVOLVED IN THE REPORTED INCIDENT. SINCE THE OPERATING TABLE MALFUNCTION WAS FOUND, IT WAS DETERMINED THAT THE GETINGE DEVICE FAILED TO PERFORM ACCORDING TO ITS SPECIFIED FUNCTIONS. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS FOUND NO PAST REPORTS OF SIMILAR INCIDENTS RESULTING IN INJURY TO EITHER A PATIENT OR AN OPERATOR. THE CUSTOMER REQUESTED THAT THE AFFECTED PART WOULD BE RETAINED AND REFUSED TO RETURN THEM. SINCE THE AFFECTED PART WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER, MAKING FURTHER ANALYSIS IMPOSSIBLE. THE COMPLAINT REVIEW FOR THIS PRODUCT REVEALED THAT THE LONGITUDINAL TRANSLATION POTENTIOMETER SHOULD HAVE BEEN REPLACED A FEW WEEKS BEFORE. SOME FUNCTIONS WERE UNAVAILABLE BUT THE CUSTOMER REFUSED THE REPAIR AFTER A GETINGE TECHNICIAN INSPECTED THE PRODUCT AND PROVIDED A QUOTE. ACCORDING TO INSTRUCTION FOR USE (1180.16 EN 15, PAGE 76) DAMAGED PRODUCT MAY NOT BE USED AND YOU MAY NOT REPAIR IT YOURSELF. ADDITIONALLY, THE OPERATOR MUST ENSURE THAT THE PRODUCT IS FULLY FUNCTIONAL AND IN GOOD WORKING ORDER PRIOR TO USE (1180.16 EN 15, PAGE 16). BASED ON ALL AVAILABLE INFORMATION IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR DUE TO USING DEVICE NOT REPAIRED WITH SOME FUNCTIONS UNAVAILABLE. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE REPORTED ISSUE, NAMELY THE DEVICE FAILING TO FUNCTION PROPERLY CREATING A RISK OF DISRUPTION IN THE EMERGENCY SURGICAL PROCEDURE, WAS RELATED TO USER ERROR. 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 CORRECTION OF G1 CONTACT PERSON ¿ MFG SITE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS G1 CONTACT PERSON ¿ MFG SITE: (B)(6). CORRECTED G1 CONTACT PERSON ¿ MFG SITE: (B)(6).

Description of Event or Problem

(B)(4).