BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVII

    MDR report key: 8755274 · Received July 2, 2019

    Report

    Report Number
    3006340424-2019-00001
    Event Type
    Death
    Date Received
    July 2, 2019
    Date of Event
    June 19, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MONICA HEALTHCARE LTD
    Product Code
    OSP
    PMA / PMN Number
    K140862
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. ON JULY 2, 2019, GE HEALTHCARE PERSONNEL VISITED THE SITE OF THE EVENT. THE NOVII INTERFACE, NOVII POD, NOVII CABLES, AND NOVII POWER SUPPLY WERE TESTED AND FOUND TO BE FUNCTIONING ACCORDING TO MANUFACTURER SPECIFICATIONS. TESTING DID IDENTIFY ISSUES WITH TWO OF THE THREE NOVII PODS, BUT THESE ISSUES WERE PROVEN TO BE INCAPABLE OF CONTRIBUTING TO THE EVENT (FETAL HEART RATE (FHR) GAP DURING MONITORING). ANALYSIS OF THE CARDIOTOCOGRAM TRACING (CTG) STRIP DID NOT REVEAL ANY MALFUNCTION OF THE NOVII SYSTEM. ANALYSIS OF THE EVENT AND ALERT LOGS SHOWED THAT THE SYSTEM FUNCTIONED AS INTENDED WITH RESPECT TO ALARMS. THE LOGS SHOWED THAT VISUAL ALARMS WERE TRIGGERED WITHIN 5 MINUTES OF THE FHR GAP PER THE DEVICE SPECIFICATIONS. THE ESTABLISHED ROOT CAUSE IS USER ERROR SINCE NON-REASSURING TRACING SHOULD HAVE INITIATED INTERVENTION IN A TIMELY MANNER.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. UNIQUE DEVICE IDENTIFIER: (B)(4). DEVICE EVALUATED BY MFR: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A LOSS OF FETAL HEART RATE (FHR) SIGNAL WITH NO ALARMS ALLEGEDLY RESULTING IN FETAL DISTRESS AND SERIOUS INJURY ENDING IN PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547252 NOVII UTERINE ELECTROMYOGRAPHIC MONITOR OSP MONICA HEALTHCARE LTD 107-PT-020

    Patients

    Seq Age Sex Outcome Treatment
    1 Death