BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1812838 · Received August 12, 2010

    Report

    Report Number
    1824206-2010-09298
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT INDICATED THE SOLENOID HAD NO MAGNETIC, PULL BUT IT MUST HAVE HAD IT BECAUSE HE SWITCHED THE COIL AND WIRES FROM S1 TO S3 WHICH CAUSED THE HEAD UP TO RUN THE KNEE UP AND THE KNEE DID NOT RUN THE HEAD. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE UNIT HAS NO HEAD UP FUNCTION AND THEY ARE UNABLE TO USE THE FOOT PUMP TO MANUALLY RAISE THE HEAD. HE WAS ALSO UNABLE TO RAISE THE HEAD OF THE BED WHILE IN POSITION SENSOR CALIBRATION.

    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