BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 2780682 · Received October 4, 2012

    Report

    Report Number
    9610816-2012-00436
    Event Type
    Death
    Date Received
    October 4, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K071800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A BABY'S DEATH, AFTER THE MOTHER WAS BEING MONITORED WITH M2705A AVALON FM50 FETAL MONITOR. IT WAS REPORTED THAT AN AVALON FM50 WAS NOT FUNCTIONAL. AN ISSUE OCCURRED AT 11:30 PM DURING A DELIVERY IN WHICH THE FM50 WAS NOT PICKED UP BY THE CENTRAL STATION (OBTV) AND THE BABY HAD A 4 1/2 MINUTES OF DECELERATION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BABY'S DEATH, AFTER THE MOTHER WAS BEING MONITORED WITH M2705A AVALON FM50 FETAL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM50 FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2705A

    Patients

    Seq Age Sex Outcome Treatment
    1