BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2091084 · Received May 12, 2011

    Report

    Report Number
    1824206-2011-02641
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE HEAD UP WOULD STILL NOT WORK IN CALIBRATION. TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO REPLACE THE S7 HEAD UP VALVE. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE BED HAS NO HEAD UP. THE MOTOR RUNS AND HE HAS REPLACED THE COIL BUT THE PROBLEM RETURNED.

    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