BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETAL MONITOR

    MDR report key: 1697304 · Received May 20, 2010

    Report

    Report Number
    9610816-2010-00163
    Event Type
    Death
    Date Received
    May 20, 2010
    Report Date
    May 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    K921957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT WHEN THY CONNECTED THE MOTHER TO THE MONITOR; THEY WERE RECEIVING TRACES EVEN THOUGH THEY WERE AWARE THAT THE BABY HAD PREVIOUSLY DIED. THE INITIAL INFO IS MOST CONSISTENT WITH MONITORING THE MOTHER INSTEAD OF THE BABY. PRODUCT LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES VERIFICATION OF FETAL VIABILITY BEFORE MONITORING AND DIFFERENTIATION BETWEEN THE MOTHER'S HEART RATE (HR) AND THE BABY'S HR. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT, 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

    THE CUSTOMER REPORTED THAT WHEN THEY CONNECTED THE MOTHER TO THE MONITOR, THEY WERE RECEIVING TRACES EVEN THOUGH THEY WERE AWARE THAT THE BABY HAD DIED AT LEAST 24 HOURS BEFORE THE MONITORING BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR HFM PHILIPS MEDICAL SYSTEMS M1351A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death