BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INO THERAPEUTICS

    MDR report key: 332415 · Received May 7, 2001

    Report

    Report Number
    332415
    Event Type
    Malfunction
    Date Received
    May 7, 2001
    Date of Event
    February 11, 2001
    Report Date
    May 7, 2001
    Manufacturer
    INO THERAPEUTICS
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHILE NITRIC OXIDE ON AMBIENT AIR WAS BEING CHECKED MACHINE SHOWED "MONITOR FAILURE" AND "ELECTRONIC SHUTDOWN". PATIENT WAS AMBUED MANUALLY AND MACHINE CHANGE OUT. MANUFACTURER CLAIMS THIS WAS DUE TO "OPERATOR ERROR" DESPITE FACT MACHINE SHOWED ERROR CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20907 INO THERAPEUTICS INOVENT TRANSPORT COMPLETE MRN INO THERAPEUTICS 6444 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other