BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1960397 · Received December 16, 2010

    Report

    Report Number
    3004531588-2010-00139
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 16, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX (B)(4) HAD READINGS THAT WERE FLUCTUATING BETWEEN 14 AND 24 PARTS PER MILLION OF INHALED NITRIC OXIDE. AFTER IT HAD BEEN SWITCHED OUT, WHILE PERFORMING ADDITIONAL TROUBLESHOOTING OF THE DEVICE, IT WAS ALSO FOUND THAT THE INJECTOR TUBING OUTLET PORT MAKES A HIGH PITCHED WHISTLING NOISE, WHICH WAS LOUDER AT HIGHER DOES SETTINGS. THE DEVICE IS PENDING INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX (B)(4) HAD READINGS THERE WERE FLUCTUATING BETWEEN 14 AND 24 PARTS PER MILLION (PPM) OF INHALED NITRIC OXIDE, WHILE ON A PT. THE RESPIRATORY THERAPIST DID A LOW AND HIGH CALIBRATION WITHOUT EFFECT. (B)(6) SUPPORT INFORMED THE RESPIRATORY THERAPIST TO REMOVE THE SAMPLE LINE FROM THE FRONT OF THE DEVICE AND SAMPLE ROOM AIR. THE NITRIC OXIDE (NO) READINGS RANGE BETWEEN MINUS 5 TO 20 PPM. THE DEVICE WAS SWITCHED OUT, AND THE RESPIRATORY THERAPIST STATED THERE WAS NO IMPACT TO THE PT. WHILE PERFORMING ADDITIONAL TROUBLESHOOTING OF THE DEVICE AFTER IT WAS SWITCHED OUT, IT WAS ALSO FOUND THAT THE INJECTOR TUBING OUTLET PORT MAKES A HIGH PITCHED WHISTLING NOISE, WHICH WAS LOUDER AT HIGHER DOSE SETTINGS. 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