BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 3994432 · Received July 23, 2014

    Report

    Report Number
    3004729605-2014-00002
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 5, 2014
    Report Date
    July 18, 2014
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS INTERMITTENTLY SHUTTING DOWN WHICH IS CAUSING INCONVENIENCE. AWAITING THE DEVICE FOR FURTHER INVESTIGATION. NO HARM TO PT REPORTED AND NO ADD'L TREATMENT NEEDED.

    Description of Event or Problem · 1

    THE SYSTEM IS INTERMITTENTLY SHUTTING DOWN WHICH IS CAUSING INCONVENIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431814 STAN S31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB STAN S31

    Patients

    Seq Age Sex Outcome Treatment
    1