BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1922898 · Received November 12, 2010

    Report

    Report Number
    3004531588-2010-00122
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX DS # (B)(4) READINGS FLUCTUATED BETWEEN MINUS 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 READINGS FLUCTUATE BETWEEN MINUS 5 TO 20 PARTS PER MILLION (PPM) WHILE ON A PT. A LOW CALIBRATION DID NOT FIX THE PROBLEM SO THE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE RESPIRATORY THERAPIST STATED THERE WAS NO IMPACT TO THE PT AND NO ADVERSE EVENT OCCURRED. IKARIA TECHNICAL SUPPORT HAD THE RESPIRATORY THERAPIST POWER ON THE INOMAX DS, # (B)(4) DEVICE, AND WHILE SAMPLING ROOM AIR, THE UNIT CONTINUED TO FLUCTUATE SIGNIFICANTLY. 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