BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1781227 · Received July 29, 2010

    Report

    Report Number
    3004531588-2010-00017
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPIRATORY THERAPIST REPORTS A LEAK FROM INOMAX DS DEVICE (B)(4). SHE STATES THE DEVICE IS READING HIGHER THAN IT IS SET AND THE INOMAX CYLINDER PRESSURE IS DROPPING. 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, CORRECTING THE INTERNAL LEAK AND LOW NITRIC OXIDE PRESSURE ALARMS. THE ROOT CAUSE OF THE INCIDENT WAS A FAILED PRESSURE SWITCH.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTS A LEAK FROM INOMAX DS DEVICE (B)(4). SHE STATES THE DEVICE IS READING HIGHER THAN IT IS SET AND THE INOMAX CYLINDER PRESSURE IS DROPPING. THE DEVICE WAS NOT ON A PATIENT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. (B)(6) TECHNICAL SUPPORT ADVISED TO HAVE THE DEVICE REPLACED WITH ANOTHER UNIT.

    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 100003

    Patients

    Seq Age Sex Outcome Treatment
    1