BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 1622600 · Received March 1, 2010

    Report

    Report Number
    9610816-2010-00042
    Event Type
    Death
    Date Received
    March 1, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K071800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 12, 2010, PHILIPS RECEIVED A MEDWATCH STATING THAT THE BABY DIED ONE DAY AFTER THE DELIVERY. THE CUSTOMER MADE IT CLEAR IN THE MEDWATCH THAT THERE HAVE BEEN DIFFICULTIES DISTINGUISHING BETWEEN THE BABY'S AND THE MATERNAL HR. AND THEREFORE, A C-SECTION WAS PERFORMED. THE CUSTOMER MADE IT CLEAR THAT THE CLINICIANS WERE AWARE OF THE ISSUE AND MADE NO ALLEGATION OR INDICATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. IN ADDITION, THERE IS NO ALLEGATION OF A PRODUCT MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).

    Description of Event or Problem · 1

    ON FEBRUARY 12, 2010, PHILIPS RECEIVED A MEDWATCH REPORT STATING THAT THE BABY DIED ONE DAY AFTER THE DELIVERY.

    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 Death