BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2190697 · Received July 29, 2011

    Report

    Report Number
    1824206-2011-04015
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    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

    TECH ISOLATED ISSUE TO HEAD HILOW DOWN VALVE. INFO PROVIDED TO FACILITY. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT THE HEAD HILOW IS SLOWLY DRIFTING DOWN. 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