BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1813221 · Received August 18, 2010

    Report

    Report Number
    1824206-2010-09405
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE UCM BOARD TO REPAIR THE BED AND CAUTIONED THE STAFF ON SPRAYING SOLUTIONS DIRECTLY ON THE BED SIDERAILS.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE BED WAS ALARMING WITH MULTIPLE 10-065 ALARM CODES. AFTER REMOVING THE LEFT INTERMEDIATE SIDERAIL COVER, FLUID WAS INSIDE THE SIDERAIL AND SIGNS OF PREVIOUS CONTAMINATION ON THE UCM BOARD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1