BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 1819722 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00002
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    May 8, 2007
    Report Date
    August 20, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAN DEVICE WAS MONITORING A TERM DELIVERY WITH VARIABLE DECELERATIONS, SCALP PH 7.36 (NORMAL). DURING THE PROGRESS OF LABOR, INADEQUATE SIGNAL QUALITY WITH NO ST INFO. PROGRESSIVELY WORSENING CTG AND PRIOR TO DELIVERY PRETERMINAL. VACUUM EXTRACTION IS PERFORMED, BUT THE BABY IS DELIVERED DEAD. THE EVENT WAS REPORTED TO FINNISH AUTHORITIES. IN RESPONSE TO THE FDA WARNING LETTER OF AUGUST 4, 2010, AND CAPA PROJECT (B)(4), THIS EVENT WILL BE REPORTED IN THE UNITED STATES ACCORDING TO THE TABLE BELOW. WE ARE AWARE THAT REPORTING TIMELINES CANNOT BE MET WITH THE RETROSPECTIVE REPORTING.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT DURING MONITORING OF A TERM LABOR, THERE WAS THE ONSET OF VARIABLE DECELERATIONS. THE SCALP PH WAS 7.36 (NORMAL). STAN MONITORING CONTINUED WITHOUT ST ANALYSIS DETERMINED DUE TO POOR SIGNAL QUALITY. THE CTG BECAME PROGRESSIVELY WORSE, AND THERE WAS A PRETERMINAL TRACING PRIOR TO DELIVERY. THERE WAS NO EARLIER INTERVENTION AND A DEAD BABY WAS DELIVERED BY VACUUM EXTRACTION.

    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 SYS101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GOLDTRACE FETAL SCALP ELECTRODE