BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2221743 · Received August 17, 2011

    Report

    Report Number
    1824206-2011-04341
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO INSPECT THE HI/LOW DRIVE BALL SCREW ASSEMBLY. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE HI/LOW FUNCTION IS DRIFTING DOWN SLOWLY. THE ACCOUNT HAS REPLACED THE HI/LOW MOTOR BUT THE ISSUE REMAINS.

    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