BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1850095 · Received September 28, 2010

    Report

    Report Number
    1824206-2010-10178
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Removal / Correction Number
    Z-0548-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE BRAKE DETENT TO REPAIR THE BED. MOD 424 IS A FIELD CORRECTIVE ACTION WHICH REPLACES THE BRAKE DETENT MECHANISM, BRAKE/STEER PEDALS AND ADJUSTS ALL FOUR CASTERS OF THE AFFINITY 4 BIRTHING BED. THIS FAILURE OCCURRED POST MODIFICATION.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES, THE BRAKE PEDAL WOULD RELEASE FROM THE LOCKED POSITION IF THE BED IS BUMPED.

    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