BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1181954 · Received September 26, 2008

    Report

    Report Number
    1824206-2008-03612
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITIES BIOMEDICAL TECHNICIAN ISOLATED THE CAUSE OF THE UNINTENTIONAL MOVEMENT TO THE LEFT SIDERAIL CONTROL BOARD. THE CONTROL BOARD WAS REPLACED TO REPAIR THE BED.

    Description of Event or Problem · 1

    ALLEGED THE UNINTENTIONAL MOVEMENT OF THE BEDS HEAD SECTION FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1