BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1070241 · Received June 30, 2008

    Report

    Report Number
    1824206-2008-02749
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    November 5, 2007
    Report Date
    November 5, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Removal / Correction Number
    Z-0617-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM FIELD INVESTIGATION INDICATED THE BRAKES WOULD NOT HOLD ON THE BED. AFTER UNSUCCESSFUL ATTEMPTS TO ADJUST THE BRAKES IN THE FIELD, HILL-ROM ENGINEERING REQUESTED THE BED BE RETURNED. ENGINEERING FOUND THAT THE BRAKES, AS THEY WERE ADJUSTED IN THE FIELD, DID NOT HOLD PROPERLY WHEN THE BED WAS PUSHED AND TUGGED ON. ENGINEERING PROCEEDED TO READJUST THE CASTERS PER PROCEDURE AND WERE ABLE TO GET THE BRAKES TO HOLD PROPERLY. ENGINEERING CONCLUDED THE CASTERS WERE NOT ADJUSTED PROPERLY IN THE FIELD. 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

    BRAKES WILL NOT STAY LOCKED ON THE BED.

    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