BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 2031648 · Received February 24, 2011

    Report

    Report Number
    1824206-2011-01100
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN ISOLATED THE PROBLEM TO THE BED EXIT SENSORS. HE REPLACED THE BED EXIT SENSORS TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BED EXIT ALARMS ON THEIR ICU. BEDS WERE NOT ALWAYS ALARMING WHEN PATIENTS ATTEMPTED TO EXIT THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1