BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC

    MDR report key: 2052436 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01619
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE HEAD HI/LOW UP AND DOWN VALVE STEM AND SOLENOID TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES, THE HEAD HI/LOW FUNCTION IS DRIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BARIATRIC AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1