BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1812868 · Received August 12, 2010

    Report

    Report Number
    1824206-2010-09307
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPLACED THE POWER CONTROL MODULE TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE HEAD AND KNEE FUNCTIONS WILL NOT RISE WHEN USING THE RIGHT OR LEFT SIDERAIL CONTROLS, THERE IS NO OPERATION MANUALLY AND THE PUMP IS NOT RUNNING. THE HEAD ANGLE IS CURRENTLY AT 29 DEGREES AND CAN BE LOWERED USING THE CPR PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1