BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1823751 · Received August 26, 2010

    Report

    Report Number
    3004531588-2010-00051
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 26, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED LEAKING FROM THE BACK OF 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 WAS A FAILED PRESSURE SWITCH.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED LEAKING FROM THE BACK OF INOMAX DS, (B)(4). THE DEVICE WAS NOT ON A PATIENT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND IS SCHEDULED TO BE 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