BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DE (DELIVERY SYSTEM)

    MDR report key: 1786174 · Received July 30, 2010

    Report

    Report Number
    3004531588-2010-00020
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    INO THERAPEUTICS LLC / IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPIRATORY THERAPIST REPORTED INOMAX DS DEVICE (B)(4) HAD FLUCTUATING MONITORED NITRIC OXIDE (NO) READINGS OF 35, 22, AND 18 WHEN THE DEVICE WAS SET AT 25 PARTS PER MILLION (PPM) OF NO. 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 DEVICE (B)(4) HAD FLUCTUATING MONITORED NITRIC OXIDE (NO) READINGS OF 35, 22, AND 18 WHEN THE DEVICE WAS SET AT 25 PARTS PER MILLION (PPM) OF NO. THE RESPIRATORY THERAPIST DID NOT PROVIDE PT OR TREATMENT INFO BUT WHEN ASKED BY (B)(4) CUSTOMER CARE, SHE STATED THERE WAS NO IMPACT TO PT AND NO ADVERSE EVENT OCCURRED. THE DEVICE IS SCHEDULE TO BE REPLACED WITH ANOTHER UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1