BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1872715 · Received October 8, 2010

    Report

    Report Number
    1824206-2010-10385
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT ONE STRAP WAS MISSING AND THE OTHER LOOSE ON THE LOWER LIFT ARM. THIS MAY HAVE CAUSE THE FRAME TO TWIST SLIGHTLY, HITTING LIFT ARM AND AFFECTING TREND. THE TECHNICIAN REPLACED THE RETAINING STRAP WITH A NEW BUSHING AND SCREWS TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE BED IS NOT GOING INTO TRENDELENBURG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1