BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVII

    MDR report key: 14218843 · Received April 27, 2022

    Report

    Report Number
    3006340424-2022-00001
    Event Type
    Death
    Date Received
    April 27, 2022
    Date of Event
    June 24, 2020
    Report Date
    September 9, 2022
    Manufacturer
    MONICA HEALTHCARE LTD
    Product Code
    OSP
    PMA / PMN Number
    K140862
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION PROVIDED. SERIAL NUMBER: NOT PROVIDED. REPORT SOURCE: (B)(6). DATE OF DEVICE MANUFACTURE: UNKNOWN AS NO SERIAL NUMBER PROVIDED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS USE ERROR RELATED TO DELAY IN EXECUTION OF THE CLINICAL PROCEDURES AS NECESSITATED AT THE TIME OF THE INCIDENT AS PER THE STANDARD OF CARE. THE DEVICE WAS FOUND TO BE FUNCTIONING AS INTENDED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT ON (B)(6) 2020 AT 7:10 AM, THE STAFF REPORTED LOSS OF SIGNAL FOR 40 MINUTES, AND NO FETAL HEART RATE. ATTENDING HEALTHCARE PROVIDERS REPORTEDLY WERE CHANGING LEADS AND DOING OTHER THINGS BECAUSE THEY DIDN'T REALIZE THAT IT WASN'T A CONNECTIVITY ISSUE, IT WAS AN ISSUE WITH THE BABY. AT 8:00 AM, A CAESARIAN SECTION WAS PERFORMED. THE BABY DIED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970190 NOVII UTERINE ELECTROMYOGRAPHIC MONITOR OSP MONICA HEALTHCARE LTD 107-PT-020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death