BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1940408 · Received December 9, 2010

    Report

    Report Number
    1824206-2010-11488
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND BED EXIT SOUND WAS TURNED OFF ON THE GRAPHICAL CAREGIVER INTERFACE (GCI). THE TECH TURNED THE ALARM AUDIBLE ON AND PROVIDED INSTRUCTION TO THE CAREGIVER.

    Description of Event or Problem · 1

    THE CAREGIVER ALLEGED THAT THE BED EXIT ALARM IS NOT AUDIBLE WHEN ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1