BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAXDS

    MDR report key: 3682710 · Received March 11, 2014

    Report

    Report Number
    3682710
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 31, 2014
    Report Date
    March 4, 2014
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 0026 RN CALLED RT TO COME AND CHECK THE NITRIC TANK. WHEN RT ARRIVED IN THE PT'S ROOM, THE SAMPLING LINE WAS IN THE NURSES HAND, IT HAD SOMEHOW COME OUT OF THE CIRCUIT. WHEN RT PLACED IT BACK IN LINE, THE INOVENT WAS READING 28PPM, WHEN THE MACHINE WAS SET TO DELIVER 5PPM. RT CALLED THE CHARGE THERAPIST AND THE SUPERVISOR TO HELP TROUBLE SHOOT. PT WAS SWITCHED TO A NEW INOVENT MACHINE. THE PT'S VITALS, REMAINED STABLE DURING THE ENTIRE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146251 INOMAXDS APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA INOMAXDS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR NOT APPLICABLE.