BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 12779285 · Received November 9, 2021

    Report

    Report Number
    2242352-2021-00940
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 20, 2021
    Report Date
    January 20, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQQ
    UDI-DI
    00607567700826
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE #(B)(4). UPDATED SECTION: G4, G7, H2, H6, H10 ANALYSIS OF PRODUCTION: (3331/213/67) THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE REPORTED SERIAL/LOT 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) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME SERIAL/LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD NOV 2019 THROUGH OCT 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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY WAS NOT WORKING PROPERLY. THEY WERE REQUIRED TO TURN UP SETTING "REALLY HIGH" TO GET THE ENERGY TO WORK WITH THE HP DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681187 T.W. POWER SUPPLY APPARATUS, CAUTERY, RADIOFREQUENCY, BATTERY-POWERED HQQ MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY 00607567700826

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male