BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY IV BED

    MDR report key: 2050163 · Received April 5, 2011

    Report

    Report Number
    1824206-2011-02013
    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
    Removal / Correction Number
    Z-0548-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE DETENT WAS SHATTERED. THE TECHNICIAN PERFORMED THE MOD AND ADJUSTED ALL BRAKE CASTERS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BED WAS STUCK IN STEER. 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