BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU BED

    MDR report key: 1964137 · Received December 21, 2010

    Report

    Report Number
    1824206-2010-11839
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE WIRING HARNESS TO REPAIR THE BED. THIS WIRING HARNESS IS UNDER A COVER AND IS NOT EXPOSED TO THE PT OR CAREGIVER.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE SIDERAIL CONTROLS ARE NOT WORKING. THE TECHNICIAN FOUND THE WIRING HARNESS FROM THE MOTOR TO THE CIRCUIT BOARD LOOKED BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCU BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 894

    Patients

    Seq Age Sex Outcome Treatment
    1