BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2241338 · Received September 2, 2011

    Report

    Report Number
    1824206-2011-04620
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN ISOLATED THE ISSUE TO A STICKING CPR VALVE. HE REPLACED THE VALVE TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE HEAD SECTION WILL NOT GO DOWN USING THE CPR LEVER, BUT WILL LOWER USING THE SIDERAIL CONTROLS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1