BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAN S31 FETAL HEART RATE MONITOR

    MDR report key: 2571358 · Received September 9, 2010

    Report

    Report Number
    3004729605-2010-00011
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    April 9, 2010
    Report Date
    September 8, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO NEOVENTA. IN THE REPORT FROM THE CUSTOMER NO DEVICE FAILURE IS DESCRIBED. POOR INTERPRETATION OF FETAL HEART RATE IS A KNOWN PROBLEM IN FETAL MONITORING. THE DEVICE IS IN USE IN THE HOSP.

    Description of Event or Problem · 1

    ADVERSE EVENT REPORTED BY THE LABOR AND DELIVERY UNIT TO (B)(6), (B)(6) WITH A COPY TO NEOVENTA BY MAIL. THE EVENT IS DESCRIBED AS A POOR INTERPRETATION OF FETAL HEART RATE (CTG) RESULTING IN A C/S WITH A BABY BORN WITH APGAR SCORE 0,2,2. THE BABY WAS TRANSFERRED TO (B)(6) FOR FURTHER TREATMENT. THE DEVICE USED FOR MONITORING WAS A STAN S31 CTG, INCLUDING SOFTWARE WITH ONLY FETAL HEART RATE TRACING AND NO ST ANALYSIS OF THE FETAL ECG.

    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/CTG 0860030

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R