BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS DELIVERY SYSTEM

    MDR report key: 5187505 · Received October 29, 2015

    Report

    Report Number
    5187505
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 11, 2015
    Report Date
    October 23, 2015
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INO DEVICE IN USE, NO READING FAILED. WENT THROUGH TROUBLESHOOTING PROCEDURE OUTLINED IN MANUAL (LOW CAL, HIGH CAL, ETC) AND DEVICE READ "FAILED NO SENSOR". DEVICE WAS SWAPPED OUT, TAKEN OUT OF USE AND IKARIA NOTIFIED. PATIENT WAS STABLE THROUGHOUT, INO DELIVERY WAS NOT AFFECTED. MANUFACTURER RESPONSE FOR INO DELIVERY, IKARIA (PER SITE REPORTER): UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719452 INOMAX DS DELIVERY SYSTEM APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA INOMAXDSIR

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR OTHER, NITRIC OXIDE