BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1062752 · Received June 18, 2008

    Report

    Report Number
    1824206-2008-02692
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WOULD NOT HOLD AND THE STEER CASTER WOULD NOT LOCK INTO THE STEER POSITION. THE TECHNICIAN FOUND THE BRAKE-STEER CASTER WAS INSTALLED INCORRECTLY. THE BRAKE/STEER CASTER WAS INSTALLED IN THE CORRECT POSITION TO REPAIR THE BED.

    Description of Event or Problem · 1

    ALLEGED THE BRAKE PEDAL WILL "POP" OUT OF THE BRAKE POSITION WHEN THE BED IS MOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK