BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETALGARD 3000

    MDR report key: 125541 · Received October 8, 1997

    Report

    Report Number
    2510954-1997-00010
    Event Type
    Death
    Date Received
    October 8, 1997
    Date of Event
    October 1, 1997
    Report Date
    October 8, 1997
    Manufacturer
    ANALOGIC
    Product Code
    KXN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INFANT WAS STILLBORN AND THAT THE FETAL MONITOR WAS INDICATING A HEART RATE. THE VALUE OF THE HEART RATE DETECTED WAS NOT REPORTED. THE USER HAS QUARANTINED THE MONITOR AND WILL NOT YET ALLOW THE MFR TO INDEPENDENTLY TEST AND/OR INSPECT THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETALGARD 3000 FETAL MONITOR KXN ANALOGIC UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death