BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1070229 · Received June 30, 2008

    Report

    Report Number
    1824206-2008-02622
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    December 28, 2007
    Report Date
    December 28, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Removal / Correction Number
    Z-0617-2008
    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 TO BRAKE PEDAL WOULD NOT LOCK IN THE BRAKE POSITION. THE HILL-ROM FIELD TECHNICIAN ADJUSTED THE CASTERS TO REPAIR THE BED. MOD 373 IS A FIELD CORRECTIVE ACTION WHICH REPLACES THE BRAKE DETENT MECHANISM AND ADJUSTS ALL FOUR CASTERS OF THE AFFINITY 4 BIRTHING BED. THIS FAILURE OCCURRED FOLLOWING THE CORRECTION OF THIS UNIT.

    Description of Event or Problem · 1

    ALLEGED THE BRAKE WAS SET ON THIS BED, AND IT JUMPED INTO THE NEUTRAL POSITION WHILE THE PATIENT WAS ENTERING THE BED. THE PATIENT SLIPPED BUT WAS BEING ASSISTED, AND DID NOT FALL.

    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