BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1905693 · Received November 12, 2010

    Report

    Report Number
    1824206-2010-11001
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO ISOLATE THE SIDERAILS TO SEE IF A SWITCH PACKAGE WAS CAUSING THIS UNINTENTIONAL MOVEMENT. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED'S HI/LOW WAS IN THE HIGHEST POSITION AND WOULDN'T LOWER. HE WAS ABLE TO MANUALLY LOWER THE HI/LOW USING THE CRANK. THE BED'S HI/LOW BEGAN TO RISE BACK UP BY ITSELF. THE BED WAS IN THE REPAIR SHOP WHEN THIS HAPPENED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1