T.W. POWER SUPPLY

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

INTERNAL COMPLAINT NUMBER: (B)(4). ANALYSIS OF PRODUCTION FOR OEM DEVICES: (3331/213/67) THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE REPORTED SERIAL NUMBER. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH. HISTORICAL DATA ANALYSIS: (4109/213/67) THIS IS AN OEM DEVICE AND THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, A QUERY OF SIMILAR COMPLAINTS FOR THE SERIAL NUMBER AND THE REPORTED FAILURE MODE WAS NOT PERFORMED. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (B)(6) 2019 THROUGH (B)(6) 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. DEVICE NOT RETURNED: (4114/3221/67) DESPITE REQUEST AND/ OR CUSTOMER INDICATION THAT THE DEVICE WOULD BE RETURNED; HOWEVER, NO DEVICE WAS RETURNED.

Additional Manufacturer Narrative

TRACKWISE ID # (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

Description of Event or Problem

THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY S/N (B)(4) DIDN¿T DELIVER ANY ENERGY IN ANY WAY. IT WORKED FINE IN THE PREVIOUS CASE, AND WHEN THEY WERE PREPARING TO START THE NEXT CASE IT NEVER WORKED. IT STOPPED WORKING BEFORE THE DEVICE WAS EVEN USED. THERE WAS NO PATIENT INVOLVEMENT SINCE IT STOPPED WORKING BEFORE THE DEVICE WAS EVEN USED. WARRANTY EXPIRED MAY/29/21.