BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1931288 · Received November 10, 2010

    Report

    Report Number
    3004531588-2010-00116
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INO THERAPEUTICS, LLC / IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX DS (B)(4) HAD ERRATIC READINGS FROM NEGATIVE 5 TO 20 PARTS PER MILLION (PPM). THE DEVICE IS IN TRANSIT FOR INVESTIGATION. THE SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX DS (B)(4) HAD ERRATIC READINGS FROM NEGATIVE 5 TO 20 PARTS PER MILLION (PPM). THE RESPIRATORY THERAPIST STATES THERE WAS NO HARM TO PT AND NO ADVERSE EVENT OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS, LLC / IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1