BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOVENT

    MDR report key: 1220574 · Received November 3, 2008

    Report

    Report Number
    2112667-2008-00046
    Event Type
    Death
    Date Received
    November 3, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    MRN
    PMA / PMN Number
    K974562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PER REPORT FROM DISTRIBUTOR: "PATIENT CARE BEING DONE ON BABY - BABY WAS TURNED - JET VENTILATOR PUT INTO STAND-BY MODE. HIGH NO ALARMED. INOVENT WORKED AS INTENDED WHEN 100 PPM REACHED. BABY MANUALLY RESUSCITATED. INOVENT REPLACED. RECALIBRATED NEW INOVENT IN 15 MINUTES. PATIENT BACK ON INOVENT, BUT NEVER FULLY RECOVERED. SHUT DOWN OCCURRED 4 TO 5 HOURS PRIOR TO PATIENT DEATH. AFTER INOVENT SHUT DOWN, BABY DECOMPENSATED AND HR INCREASED, AND WAS MANUALLY RESUSCITATED. PATIENT'S STATUS DETERIORATED AND NEVER RETURNED TO PREVIOUS STATUS. APPROXIMATELY 2 HOURS LATER, BOWEL PERFORATION FIRST NOTICED. PATIENT HAD SURGERY FOR BOWEL PERFORATION, BUT PATIENT'S STATUS NEVER CAME BACK TO BASELINE. PATIENT WENT INTO DIC AND DID NOT RECOVER." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVENT NITRIC OXIDE DELIVERY SYSTEM MRN DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death