BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1946334 · Received December 14, 2010

    Report

    Report Number
    1824206-2010-11589
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    INFO RECEIVED ALLEGED THAT THE HEAD HI/LOW IS DRIFTING DOWN SLOWLY. NO INJURIES WERE REPORTED. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1900K006231

    Patients

    Seq Age Sex Outcome Treatment
    1