BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 2221771 · Received August 17, 2011

    Report

    Report Number
    1824206-2011-04344
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, THE TECH FOUND THAT THE BALL SCREW ASSEMBLE WAS DRY AND VERY DIRTY AND THE MOTOR COUPLER WAS CRACKED. HE CLEANED AND LUBRICATED THE BALL SCREW ASSEMBLY AND REPLACED THE MOTOR COUPLER, BUT THE BED CONTINUED TO DRIFT. HE REPLACED THE BALL SCREW ASSEMBLY TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE BED WAS NOISY AND WHEN RAISED, WOULDN'T STAY UP ALL THE TIME, IT WOULD DRIFT DOWN SLOWLY.

    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