BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1800026 · Received August 11, 2010

    Report

    Report Number
    3004531588-2010-00033
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 11, 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

    A RESPIRATORY THERAPIST REPORTS AN INTERNAL LEAK AND LOUD COMING FROM BEHIND THE HEAD OF DEVICE INOMAX DS (B)(4). EVALUATION SUMMARY: THE INVESTIGATION OF THE DEVICE IS COMPLETE AND IS AS FOLLOWS: THE DEVICE WAS CONFIRMED TO HAVE A LEAK THAT WAS TRACED TO THE PRESSURE SWITCH. THE PRESSURE SWITCH WAS REPLACED AND IT WAS CONFIRMED THE LEAK STOPPED AND WAS CORRECTED. THE ROOT CAUSE OF THE INCIDENT PRESSURE SWITCH.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTS AN INTERNAL LEAK AND LOUD NOISE COMING FROM BEHIND THE HEAD OF DEVICE INOMAX DS (B)(4). THE DEVICE WAS NOT ON A PT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND SCHEDULED FOR RETURN 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