BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INO VENT

    MDR report key: 562471 · Received December 7, 2004

    Report

    Report Number
    MW1033948
    Event Type
    Malfunction
    Date Received
    December 7, 2004
    Date of Event
    December 5, 2004
    Report Date
    December 7, 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 PLAN WAS TO WEAN THE NO OFF THE PATIENT. THEY WEANED TO 0.5 PPM. THE NO ANALYZER READ LESS THAN ZERO. THEY INITIATED A LOW CAL THAT FAILED, AND THE VENT BECAME INOPERABLE. THEY REMOVED THE NO FROM THE PT. THEY INCREASED THE FIO2 BY 8%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INO VENT INO DELIVERY SYSTEM MRN INO THERAPEUTICS 6645 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY