BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES 50 XM FETAL/MATERNAL MONITOR

    MDR report key: 2264143 · Received September 21, 2011

    Report

    Report Number
    9610816-2011-00560
    Event Type
    Death
    Date Received
    September 21, 2011
    Report Date
    September 16, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K900480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A MATERNAL PT PRESENTED WITH FETAL DISTRESS. THE CLINICIANS LOST FETAL HEART RATE (FHR) MONITORING SIGNAL USING AN ULTRASOUND TRANSDUCER AND THEN THEY RECEIVED A INOP MESSAGE WHEN CONNECTING THE DECG AND COULD NOT GE A FHR. THE FETUS WAS DELIVERED BY NORMAL DELIVERY AND DIED LATER AFTER THE DELIVERY. THE CUSTOMER AND THE LOCAL PHILIPS STAFF PROVIDED THIS INFORMATION ON HOW TO TEST CABLES. 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 MATERNAL PT PRESENTED WITH FETAL DISTRESS. THE CLINICIANS LOST FETAL HEART RATE (FHR) MONITORING SIGNAL USING AN ULTRASOUND TRANSDUCER AND THEN THEY RECEIVED A INOP MESSAGE WHEN CONNECTING THE DECG AND COULD NOT GET A FHR. THE FETUS WAS DELIVERED BY NORMAL DELIVERY AND DIED LATER AFTER THE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 50 XM FETAL/MATERNAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M1350B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death