BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAN S31 FETAL HEART RATE MONITOR

    MDR report key: 1359066 · Received April 9, 2009

    Report

    Report Number
    3004729605-2008-00001
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    January 10, 2008
    Report Date
    October 9, 2008
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A BABY MONITORED WITH STAN S31 WAS BORN WITH METABOLIC ACIDOSIS DEFINED BY UMBILICAL CORD ARTERIAL BLOOD SAMPLE. A FIRST REVIEW OF THE CASE INDICATED THAT THE LABOR WAS ALLOWED TO CONTINUE TOO LONG WITH NON-REASSURING FETAL HEART RATE (FHR), WHICH IS IN CLEAR VIOLATION OF THE STAN S31 GUIDELINES. THERE ARE CURRENTLY NO INDICATION FOR MALFUNCTION IN THE DEVICE, NEITHER FAULTY LABELLING NOR WEAKNESS IN METHODOLOGY. NEOVENTA HAS TRAINED THE CLINICIANS AT THE HOSP. A F/U REPORT WILL BE SUBMITTED AS SOON AS A MORE THOROUGH INVESTIGATION HAS BEEN COMPLETED. NEWBORN WAS DISCHARGED FROM THE HOSP ALIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention