BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2212889 · Received July 12, 2011

    Report

    Report Number
    1824206-2011-03680
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 23, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD TECHNICIAN FOUND A BOLT SHEARED OFF ON THE BOTTOM OF THE LIFT ARM. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE BED WENT INTO REVERSE TREND LIKE MOTION AND THE PATIENT SLID OUT OF THE BED AND ONTO HER FEET. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK