BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES 50 XM FETAL/MATERNAL MONITOR

    MDR report key: 1407704 · Received June 26, 2009

    Report

    Report Number
    9610816-2009-00069
    Event Type
    Death
    Date Received
    June 26, 2009
    Date of Event
    March 26, 2008
    Report Date
    May 15, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K90048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT DUE TO THE CHANGE OF SPEED AND A BAD SETTING, THE MIDWIVES THOUGHT THE FETUS WAS SUFFERING AND DECIDED TO PERFORM A C-SECTION, AFTER WHICH THE BABY DIED. PHILIPS MEDICAL SYSTEMS INVESTIGATED THE ISSUE AS DESCRIBED AND DETERMINED THERE WAS NO EVIDENCE TO SUPPORT A DEVICE MALFUNCTION. R & D PERFORMED AN ANALYSIS OF THE ERROR LOG AND VERIFIED THAT THE BATTERY MAINTENANCE WERE OK. THE REVIEW OF THE ERROR LOGS FOUND SEVERAL USER ISSUES, INCLUDING USE OF NON-PHILIPS PAPER WITH THE DEVICE. THEREFORE, WE CAN ONLY DETERMINE THAT THE MONITOR FUNCTIONED PER PRODUCT SPECIFICATION. THE CUSTOMER DOES NOT CLAIM A PRODUCT MALFUNCTION. THE AVAILABLE INFO DOES NOT SUPPORT THAT THE CESAREAN SECTION WAS NECESSARY OR THAT ANY USER ERROR REGARDING THE PAPER SPEED SETTING IMPACTED THE OUTCOME OF THE BABY. NO FURTHER ACTION OR INVESTIGATION WAS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DUE TO THE CHANGE OF SPEED AND A BAD SETTING, THE MIDWIVES THOUGHT THE FETUS WAS SUFFERING AND DECIDED TO PERFORM A C-SECTION WHICH RESULTED IN THE INFANT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 50 XM FETAL/MATERNAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M1350C

    Patients

    Seq Age Sex Outcome Treatment
    1