BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2003036 · Received February 8, 2011

    Report

    Report Number
    1824206-2011-00731
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    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

    HEAD IS SLOWLY DRIFTING DOWN, ABOUT 1 INCH PER 30 MIN. NO INCIDENT WAS REPORTED AS A RESULT OF THIS ISSUE. HEAD DOWN VALVE AND CPR VALVE WERE CHECKED. REPLACED THE CPR VALVE TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    COMPLAINT ALLEGED THAT THE HEAD OF THE BED IS SLOWLY DRIFTING DOWN, ABOUT 1 INCH PER 30 MIN. NO INCIDENT WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1900D004931

    Patients

    Seq Age Sex Outcome Treatment
    1