BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1964529 · Received December 22, 2010

    Report

    Report Number
    1824206-2010-11890
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 10, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE BRAKE DETENT ASSEMBLY WAS BROKEN, THE BRAKE/STEER CASTER HAD BEEN MOVED TO THE WRONG POSITION AND TWO OF THE BRAKE CASTERS WERE DAMAGED AND NON FUNCTIONAL. THE TECHNICIAN MOVED THE BRAKE/STEER CASTER TO THE CORRECT POSITION, REPLACED THE BRAKE DETENT ASSEMBLY, REPLACED THE TWO DAMAGED BRAKE CASTERS AND ADJUSTED THE BRAKE TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO REC'D INDICATES THE BRAKES ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 4 BIRTHING BED HDD HILL-ROM, INC. 3700B

    Patients

    Seq Age Sex Outcome Treatment
    1