BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 1819976 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00006
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    April 22, 2007
    Report Date
    August 19, 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 CLINIC HAS NOT PROVIDED DETAILED INFORMATION REGARDING THE CASE OR DEVICE. THE STAN REMAINS IN THE HOSPITAL. IT IS OUR UNDERSTANDING THAT THEY ARE TREATING THIS AS A USER ERROR. WE BELIEVE THERE ARE NO FAILURES WITH THE DEVICE, AND THAT THE DEVICE IS STILL IN USE. NEOVENTA BELIEVES THAT THE DEVICE IS NOT CONSIDERED THE ROOT CAUSE FOR THE INCIDENT. ALTHOUGH, THE INITIAL REPORTABILITY DECISION INDICATED THAT THIS WAS NOT A REPORTABLE EVENT IN THE US, IN RESPONSE TO THE FDA WARNING LETTER OF AUGUST 4, 2010, AND CAPA PROJECT (B)(4), THIS EVENT WILL BE REPORTED IN THE US ACCORDING TO THE TABLE BELOW. WE ARE AWARE THAT REPORTING TIMELINES CANNOT BE MET WITH THE RETROSPECTIVE REPORTING.

    Description of Event or Problem · 1

    A NEOVENTA MEDICAL AB EMPLOYEE HEARD ABOUT THIS CASE OF A POOR NEWBORN OUTCOME THAT HAS BEEN REPORTED TO THE MEDICAL BOARD IN (B)(6). THE INFORMATION WAS INTERNALLY ENTERED IN THE CLINICAL FEEDBACK LOG.

    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 SYS 101003

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Hospitalization| L| O