BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1070246 · Received June 30, 2008

    Report

    Report Number
    1824206-2008-02740
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Removal / Correction Number
    Z-0617-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    AFTER SETTING THE BRAKE ON THE BED, THE BRAKE PEDAL WILL START TO MIGRATE OUT OF THE BRAKE POSITION.

    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