BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 2031767 · Received March 21, 2011

    Report

    Report Number
    1824206-2011-01716
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNTS MAINTENANCE BELIEVES THE CASTERS ARE WORN FROM AGE. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED WHEN THEY ENGAGE THE BRAKE PEDAL, THE BRAKE DOES NOT HOLD IF THEY LEAN ON THE BED FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED HDD HILL-ROM INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1