BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1021503 · Received March 26, 2008

    Report

    Report Number
    1824206-2008-00052
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 10, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WOULD NOT HOLD ON THE BED. THE HILL-ROM TECHNICIAN FOUND WORN BRAKE/STEER CASTERS THAT COULD NOT BE ADJUSTED AND A BROKEN CAM PIVOT. THE HILL-ROM TECHNICIAN REPLACED THE CASTERS AND CAM PIVOT 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

    ACCOUNT ALLEGED THE BRAKES WOULD NOT HOLD ON THIS 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 UNK