BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1021499 · Received March 26, 2008

    Report

    Report Number
    1824206-2008-00065
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    December 20, 2007
    Report Date
    December 20, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ADJUSTED THE BRAKE/STEER CASTER TO REPAIR THE BED. THE AFFINITY SERVICE MANUAL (MAN272) 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

    ALLEGED NO BRAKE ON THE BED WHEN THE BRAKE WAS APPLIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK