BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INO VENT

    MDR report key: 561994 · Received November 22, 2004

    Report

    Report Number
    MW1033845
    Event Type
    Malfunction
    Date Received
    November 22, 2004
    Date of Event
    November 15, 2004
    Report Date
    November 22, 2004
    Manufacturer
    INO THERAPEUTICS
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INO VENTILATOR WENT INTO "ELECTRONIC DELIVERY FAILURE." PT WAS ABLE TO BE VENTILATED MANUALLY, WAS NOT COMPROMISED FROM FAILURE AND WAS REMOVED FROM VENTILATOR. THE PT WAS ABLE TO BE WEANED FROM INO AND DID NOT HAVE TO BE PUT BACK ON INO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY