BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORO 250 SERIES MATERNAL/FETAL MONITOR

    MDR report key: 1373108 · Received April 30, 2009

    Report

    Report Number
    9617277-2009-00001
    Event Type
    Death
    Date Received
    April 30, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 30, 2009
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    HGM
    PMA / PMN Number
    K050583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: GE HEALTHCARE PERFORMED A CHECKOUT OF THE MONITOR AND FOUND IT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS. GE HEALTHCARE REQUESTED A COPY OF THE MONITOR TRACINGS IN ORDER TO PERFORM A CLINICAL EVALUATION OF THE ALLEGED EVENT, HOWEVER, THE REQUEST WAS DENIED BY THE HOSPITAL. NO FURTHER INVESTIGATION OF THE ALLEGED EVENT CAN TAKE PLACE UNTIL GE HEALTHCARE IS PROVIDED A COPY OF THE TRACINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT PROVIDED A MATERNAL AND FETAL HEART RATE TRACING THROUGHOUT LABOR. PT ASSIGNED APGARS OF 0 AT ONE MINUTE AND 0 AT FIVE MINUTES. RESUSCITATION EFFORTS INCLUDING INTUBATION AND EPINEPHRINE ADMINISTRATION WERE REPORTEDLY TAKEN, BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORO 250 SERIES MATERNAL/FETAL MONITOR MATERNAL FETAL MONITOR HGM OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death