BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABTHERA

    MDR report key: 4275283 · Received October 6, 2014

    Report

    Report Number
    4275283
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    July 19, 2014
    Report Date
    October 6, 2014
    Manufacturer
    KCI USA, INC
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    ABTHERA MACHINE QUIT WORKING ON DAY SHIFT, REQUEST THROUGH EQUIMENT MANAGEMENT MADE ON DAY SHIFT. NIGHT SHIFT CALLED TO INQUIRE WHERE MACHINE WAS, TOLD IT WAS BEING DELIVERED. 2 HOURS PASS, STILL NO MACHINE, FOLLOW UP CALL RESULTED IN BEING TOLD THAT THERE WERE NO AVAILABLE MACHINES THROUGHOUT HOSPITAL INCLUDING OR. CALL PLACED TO COMPANY VIA EQUIPMENT MANAGEMENT, CLOSED FOR WEEKEND. ABTHERA MACHINE COMPLETELY FAILED, NO LONGER TURNS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622258 ABTHERA NEGATIVE PRESSURE WOUND THERAPY OMP KCI USA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *