BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUENTIAL COMPRESSION DEVICE

    MDR report key: 2112402 · Received May 29, 2011

    Report

    Report Number
    2112402
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 29, 2011
    Manufacturer
    HUNTLEIGH HEALTHCARE
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON NURSE ENTERING ROOM, SHE NOTICED THAT SEQUENTIAL COMPRESSION DEVICE WAS NOT FUNCTIONING. MOTOR WAS ON AND YOU COULD HEAR IT RUNNING, HOWEVER NO COMPRESSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENTIAL COMPRESSION DEVICE SEQUENTIAL COMPRESSION DEVICE JOW HUNTLEIGH HEALTHCARE AC 550; FLOWTRON EXCEL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR