BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 2960448 · Received January 25, 2013

    Report

    Report Number
    2242352-2013-00027
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 8, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER SUPPLY WAS INTERMITTENT. THE CORDS WERE CHANGED; HOWEVER, THE DEVICE WAS STILL ACTIVATING INTERMITTENTLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35454 T.W. POWER SUPPLY ENDOSCOPIC VESSEL HARVESTING HQO MAQUET CARDIOVASCULAR, LLC. VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA