BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 2110125 · Received May 19, 2011

    Report

    Report Number
    1824206-2011-02782
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT INDICATED THE BED HAS BEEN REPAIRED AND PUT BACK IN SERVICE BUT WAS NOT SURE WHAT WAS DONE TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNTS MAINTENANCE STATED IF THE CASTERS ON THE BED ARE POINTING HEAD TO FOOT, THEY WILL LOCK INTO PLACE WHEN THE BRAKE IS PUSHED BUT IF THEY ARE POINTING SIDE TO SIDE, THEY WILL NOT LOCK INTO PLACE.

    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