BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOVENT

    MDR report key: 511141 · Received February 4, 2004

    Report

    Report Number
    MW1031069
    Event Type
    Injury
    Date Received
    February 4, 2004
    Date of Event
    January 4, 2004
    Report Date
    January 27, 2004
    Manufacturer
    INO THERAPEUTICS
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN ICU ON INOVENT, ELECTRICAL FAILURE, NO NITRIC DELIVERY AND CONSTANT ALARM. 02 SATURATIONS DROPPED INTO 30'S. PT PLACED ON ECMO AND RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVENT * MRN INO THERAPEUTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DAY Other| R