BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1052841 · Received May 27, 2008

    Report

    Report Number
    1824206-2008-02581
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WERE DIFFICULT TO SET ON THE BED. THE HILL-ROM TECHNICIAN REPLACED THE BRAKE/STEER CASTER, BRAKE BLOCK AND TRANSLINK TO REPAIR THE BED. THE AFFINITY 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.

    Description of Event or Problem · 1

    ALLEGED WHEN THE BRAKE PEDAL IS SET AND THE BED IS LEANED ON, THE BREAK WILL NOT HOLD.

    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