BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 2917301 · Received January 11, 2013

    Report

    Report Number
    3004729605-2013-00001
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    December 2, 2012
    Report Date
    October 1, 2013
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO NEOVENTA OFFICE IN (B)(6). THE DEVICE REMAINS IN THE HOSPITAL AND NO FAILURE TO THE DEVICE HAS BEEN REPORTED. THERE IS NO OBVIOUS CAUSE OF THE OUTCOME IN THE EFM RECORDING. THERE ARE NO CORD GASES AVAILABLE UNTIL THE ARRIVAL TO THE NEONATAL UNIT AFTER MORE THAN 30 MIN OF RESUSCITATION: PH (B)(6) THE OBSTETRIC TEAM PERFORMED CORRECTLY ACCORDING TO GUIDELINES. SUSPICION OF INFECTION DUE TO HIGH CRP VALUES, AS ANTIBIOTICS WAS ADMINISTERED TO BABY PRIOR TO BLOOD CULTURE. THE PARENTS HAVE DENIED POST-MORTEM EXAMINATION.

    Description of Event or Problem · 1

    BABY MONITORED WITH EFM AND ST ANALYSIS FROM 08.00 AM. OXYTOCIN INFUSION ONGOING, MATERNAL TEMP 38.2C. FETAL BLOOD SAMPLING PH (B)(6) AT 08.45 AM. DELIVERY TERMINATED AT 11.06 AM WITH MIDCAVITY VACUUM EXTRACTION, (B)(6). BABY RESUSCITATED FOR 30 MINUTES, NO CORD BLOOD GASES AVAILABLE. FIRST PH AT ARRIVAL AT NEONATAL UNIT: 6.30. ANTIBIOTICS GIVEN TO BABY PRIOR TO BLOOD CULTURE: NEGATIVE FOR MOTHER AND BABY. BABY DIED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16739 STAN S31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB STAN S31 SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death