BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 12089680 · Received June 29, 2021

    Report

    Report Number
    2242352-2021-00522
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 7, 2021
    Report Date
    September 14, 2021
    Product Code
    HQQ
    UDI-DI
    00607567700826
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986504 T.W. POWER SUPPLY APPARATUS, CAUTERY, RADIOFREQUENCY, BATTERY-POWERED HQQ T.W. POWER SUPPLY 00607567700826

    Patients

    Seq Age Sex Outcome Treatment
    1