BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2253778 · Received August 10, 2011

    Report

    Report Number
    1824206-2011-04198
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 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

    ISOLATED THE PROBLEM TO A DEFECTIVE CPR VALVE. REPLACED THE VALVE TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THE HEAD SECTION WAS DRIFTING DOWN VERY SLOWLY. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1900

    Patients

    Seq Age Sex Outcome Treatment
    1