BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 2053536 · Received March 17, 2011

    Report

    Report Number
    1824206-2011-01681
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNTS MAINTENANCE 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 EVENT OCCURRED POST MOD.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED WHEN THEY ENGAGE THE BRAKE PEDAL INTO BRAKE, AND IF THEY BUMP THE BED, THE BRAKE PEDAL POPS OUT OF BRAKE AND BACK INTO NEUTRAL. MAINTENANCE HAS CHECKED AND ADJUSTED THE BRAKE CASTERS AND THE ISSUE RETURNED. HE BELIEVES THE BRAKE DETENT IS THE ISSUE.

    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