BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1082750 · Received July 23, 2008

    Report

    Report Number
    1824206-2008-02870
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPLACED THE BRAKE AND BRAKE/STEER CASTERS TO REPAIR THE BED. CHAPTER 6 OF THE SERVICE MANUAL (MAN013RE) DOCUMENTS A FUNCTION CHECK FOR THE CASTER TIRES AND CENTRAL BRAKE AND STEER AS PART OF PREVENTATIVE MAINTENANCE. THE COMPONENTS SHOULD BE CHECKED FOR CUTS, WEAR, TREAD LIFE, ETC. AND THE BRAKES SHOULD BE CHECKED TO ENSURE THE BED WILL NOT MOVE WHEN THE BRAKE IS ACTIVATED. IF THE BED MOVES, INSPECTION FOR WEAR AND ADJUSTMENT MAY BE NECESSARY. THE STEERING PEDAL SHOULD ALSO BE CHECKED FOR PROPER LOCKING WHEN ACTIVATED.

    Description of Event or Problem · 1

    BRAKE WILL NOT HOLD ON THE BED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1