BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW POWER SUPPLY

    MDR report key: 2211513 · Received August 5, 2011

    Report

    Report Number
    2242352-2011-01065
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW POWER SUPPLY DID NOT POWER UP; THE LIGHT DID NOT COME ON. THEY SWITCHED THE CORD ONCE AND THE POWER SUPPLY STILL WOULD NOT LIGHT UP OR EMIT ENERGY. A COMPETITOR'S UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL KEEPS TRACK OF THE CABLE USAGE. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TW POWER SUPPLY POWER SUPPLY HQO MAQUET CARDIOVASCULAR, LLC VH-3010 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI