BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETAL MONITOR

    MDR report key: 1659050 · Received April 12, 2010

    Report

    Report Number
    9610816-2010-00104
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K011304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PT DEATH OCCURRED IN UTERO DURING THE RECORDING OF A FETAL HEART RATE WITH A CARDIOGRAPH AND THE ALARM DID NOT ACTIVATE. THE PRELIMINARY INVESTIGATION HAS NOT YET CONFIRMED THAT MONITORING THE MOTHER INSTEAD OF THE BABY WAS THE CAUSE OF THE ALLEGED FAILURE TO ALARM. 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 A PT DEATH OCCURRED IN UTERO DURING THE RECORDING OF A FETAL HEART RATE WITH A CARDIOGRAPH AND THE ALARM DID NOT ACTIVATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death