BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND VAC

    MDR report key: 1872628 · Received September 27, 2010

    Report

    Report Number
    1872628
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    September 27, 2010
    Manufacturer
    KCI
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WOUND-VAC FLASHED BATTERY CRITICAL EVEN WHILE PLUGGED IN. EVENTUALLY TURNED OFF. CALLED (B) (6) MATERIAL SERVICES CENTER AND WOUND-VAC WAS SENT UP WITHIN MINUTES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUND VAC WOUND VAC OMP KCI NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR