BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVIAN CRITICAL CARE

    MDR report key: 1744439 · Received June 28, 2010

    Report

    Report Number
    MW5016554
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    DRAGER MEDICAL, INC.
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRAGER MEDICAL, INC. INNOVIAN CRITICAL CARE VF4.5 WEIGHT FUNCTION ERROR. WHEN CLINICIAN STARTS A WEIGHT BASED MEDICATION INFUSION, THE ADMISSION WEIGHT DISPLAYS IN THE DAILY WEIGHT COLUMN OF THE WEIGHT TOOL AND CREATES AN ERRONEOUS DAILY WEIGHT IN THE DAILY WEIGHT LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVIAN CRITICAL CARE INNOVIAN CRITICAL CARE NSX DRAGER MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other