BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 1990251 · Received February 10, 2011

    Report

    Report Number
    3004729605-2011-00001
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 10, 2011
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO NEOVENTA BY THE (B)(4) DISTRIBUTOR APPROX ONE MONTH AFTER THE INCIDENT TOOK PLACE. THE EXACT DATE IS UNK. TO OUR KNOWLEDGE THE STAN DEVICE REMAINS IN THE HOSP AND NO FAILURE OF THE DEVICE HAS BEEN REPORTED. THE PH OF 7.18 FROM ONE CORD VESSEL AFTER BIRTH DOES NOT INDICATE THAT THE EVENT IS RELATED TO OXYGEN DEFICIENCY AND/OR TO THE SURVEILLANCE OF THE FETUS WITH STAN S31 DURING LABOR. NEOVENTA BELIEVES THAT THE DEVICE IS NOT CONSIDERED THE ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    STILLBORN BABY MONITORED WITH STAN S31 DURING LABOR. APGAR 0/0/0. THE TEAM WAS NOT ABLE TO RESUSCITATE. AUTOPSY WILL BE PERFORMED. PH 7.18 FROM ONE CORD VESSEL AFTER BIRTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death