BEUDAMED
    FDA Adverse Event Death Summary report: N

    FETAL MONITOR SERIES 50 IP

    MDR report key: 1729585 · Received June 16, 2010

    Report

    Report Number
    9610816-2010-00195
    Event Type
    Death
    Date Received
    June 16, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 7, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A DEATH OCCURRED WHILE A PT WAS BEING MONITORED BY A PHILIPS FETAL MONITOR. THE CUSTOMER REPORTED THAT THE FETAL MONITOR HAD GIVEN THE BABY'S HEART RATE BETWEEN 140 AND 160BPM AND THEN A RANGE BETWEEN 80BPM AND 175BPM. EVEN WHEN THE BABY WAS TAKEN OUT OF HIS MOTHER, THE MONITOR CONTINUED TO SHOW A RATE OF 140BPM WHEREAS THE BABY WAS DELIVERED STILLBORN. THE AVAILABLE INFO IS FULLY CONSISTENT WITH THE CLINICIANS MONITORING THE MOTHER INSTEAD OF THE FETUS. THE AVAILABLE INFO IS NOT SUFFICIENT TO SUPPORT THAT THE USE OF THE MONITOR WAS A FACTOR IN THE STILLBIRTH. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 DEATH OCCURRED WHILE A PT WAS BEING MONITORED BY A PHILIPS FETAL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR SERIES 50 IP HFM PHILIPS MEDICAL SYSTEMS M1353A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death