BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1811219 · Received August 11, 2010

    Report

    Report Number
    1824206-2010-09267
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE SET SCREW FOR THE CASTER FELL OUT. THE ACCOUNT REPLACED THE SET SCREW TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THEY WERE RAISING THE BED ON A LIFT AND THE LEFT FOOT CASTER FELL OFF THE BED.

    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