BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVENT

    MDR report key: 3608720 · Received January 31, 2014

    Report

    Report Number
    3608720
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    December 2, 2013
    Report Date
    January 31, 2014
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INOVENT ALARMING "FAILED NITRIC CELL," SWITCHED OUT WITH ANOTHER INOVENT. UPON INSPECTION: DEVICE GENERATED A "NO CELL FAILURE" ALARM WHILE IN USE. THE DEVICE WAS LOW AND HIGH LEVEL CALIBRATED, PERFORMANCE CHECKED, AND RETURNED TO SERVICE (RTS). PER IKARIA TECH SUPPORT, THE 2 POINT CALIBRATION SLOPE DRIFTED AND REQUIRED THE LOW/HIGH LEVEL CALIBRATIONS TO BRING IT BACK INTO RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68352 INOVENT APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA INOMAXDSIR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR