BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY IV BED

    MDR report key: 2050161 · Received April 5, 2011

    Report

    Report Number
    1824206-2011-02012
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN PERFORMED THE MOD TO REPAIR THE BRAKE DETENT AND ADJUSTED ALL BRAKE CASTERS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BRAKE DETENT HAS FAILED. THE BRAKES WOULD LOCK BUT CASTERS WOULD STILL ROLL. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY IV BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1