BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 4172455 · Received October 9, 2014

    Report

    Report Number
    2242352-2014-01070
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION; THEREFORE IT COULD NOT BE EVALUATED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A BATCH/LOT REVIEW COULD NOT BE COMPLETED BECAUSE A BATCH/LOT NUMBER WAS NOT PROVIDED. NEITHER COULD A CERTIFICATE OF COMPLIANCE BE RETRIEVED WITHOUT THE BATCH/LOT NUMBER. (OEM DEVICE). (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE FIRST T.W. POWER SUPPLY PROVIDED POWER INTERMITTENTLY AND THE SECOND DID NOT PROVIDE POWER AT ALL. THE HOSPITAL SWITCHED CABLES AND USED A THIRD DEVICE AND EVERYTHING WORKED FINE. NO PATIENT EFFECTS WERE REPORTED. THE DEVICE IS NOT BEING RETURNED. IT WAS REPORTED THAT THE TWO DEVICES WORKED FINE WHEN THE EXTENSION CABLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636817 T.W. POWER SUPPLY ENDOSCOPIC VESSEL HARVESTING HQO MAQUET CARDIOVASCULAR, LLC VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1