BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 3912127 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00535
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING SERVICING THE POWER ON THE T.W. POWER SUPPLY WAS NOT BEING GENERATED ON A CONTINUAL BASIS. BIOMED CHECKED IT OUT AND PUT IT BACK INTO USE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285576 T.W. POWER SUPPLY ENDOSCOPIC VESSEL HARVESTING HQO MAQUET CARDIOVASCULAR, LLC VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1