BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 3964614 · Received May 30, 2014

    Report

    Report Number
    2242352-2014-00627
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VESSELS WERE NOT BEING SEALED WELL AND THERE WAS A BURNING SMELL "LIKE PLASTIC" COMING FROM GENERATOR. THEY DETERMINED THAT IT WAS IN ONE ROOM WITH ONE POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320082 T.W. POWER SUPPLY POWER SUPPLY HQO MAQUET CARDIOVASCULAR VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1