BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1882664 · Received October 21, 2010

    Report

    Report Number
    1824206-2010-10601
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE CAM PIVOT LINKING THE BRAKE BAR TO THE PEDAL SNAPPED AT THE FIXING POINT. THE TECHNICIAN REPLACED THE CAM PIVOT TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES ONE OF THE TWO BRAKE CASTERS IS NOT HOLDING WHEN IN BRAKE.

    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