BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1964176 · Received December 21, 2010

    Report

    Report Number
    1824206-2010-11861
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 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

    TECHNICIAN FOUND THE BED LOCATED IN STORAGE AREA AND CONFIRMED THAT THE HEAD HI-LO SECTION WAS DRIFTING DOWN. REPLACED HYDRAULIC POWER UNIT TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    INFORMATION PROVIDED ALLEGED THAT THE HEAD HI-LO SECTION KEPT DRIFTING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1900N006970

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly