BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 3853284 · Received April 4, 2014

    Report

    Report Number
    3004729605-2014-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 3, 2014
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED BY THE CUSTOMER TO THE DANISH HLTH AND MEDICINES AGENCY WHO INFORMED NEOVENTA MEDICAL (B)(4). THE REPORT WAS NOT RECEIVED DIRECTLY FROM THE CUSTOMER.

    Description of Event or Problem · 1

    ACCORDING TO THE INCIDENT REPORT, DURING THE LAST 12 MINUTES OF THE CRITICAL DELIVERY, IT HAS NOT BEEN POSSIBLE TO ASSESS AND DOCUMENT THE HEART RATE OF THE UNBORN CHILD. NO INJURY TO THE BABY WAS REPORTED. THE CUSTOMER HAS BEEN CONTACTED REGARDING ADDITIONAL INFO AND INVESTIGATION INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205226 STAN S31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB STAN S31 NA

    Patients

    Seq Age Sex Outcome Treatment
    1