BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 2517990 · Received March 28, 2012

    Report

    Report Number
    9610816-2012-00143
    Event Type
    Death
    Date Received
    March 28, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A DECEASED FETUS DURING MONITORING WITH AN AVALON FM30 FETAL MONITOR. THE CUSTOMER/STAFF ARE LOSING CONFIDENCE ON THE FETAL MOVEMENT/ALERT ON THE FM30 FETAL MONITOR. THEY WANT TO REMOVE/DISABLE THIS FEATURE AND WANTED TO KNOW THE LIABILITY/RISK. THEY'RE RECEIVING MAY FALSE POSITIVES ON AUTOMATIC FETAL MOVEMENT, FETUS IS DECEASED BUT MONITOR STILL CONTINUES TO SHOW FETAL ALERT/MOVEMENT. THE DEVICE LABELING (INSTRUCTIONS FOR USE/IFU) AVALON FETAL MONITOR FM20/30, FM40/50 RELEASE G.0 WITH SOFTWARE REVISION G.02.XX PN#453564290161 NOTES THAT: PT MONITORING. WHEN FETAL MOVEMENT PROFILE (FMP) IS ENABLED: THE FMP ANNOTATIONS ON A FETAL TRACE ALONE MAY NOT ALWAYS INDICATE THAT THE FETUS IS ALIVE. FOR EXAMPLE, FMP ANNOTATIONS IN THE ABSENCE OF FETAL LIFE MAY BE A RESULT OF: MOVEMENT OF THE DECEASED FETUS DURING OR FOLLOWING MATERNAL MOVEMENT, MOVEMENT OF THE DECEASED FETUS DURING OR FOLLOWING MANUAL PALPATION OF FETAL POSITION (ESPECIALLY IF THE PRESSURE APPLIED IS TOO FORCEFUL), MOVEMENT OF THE ULTRASOUND TRANSDUCER, FETAL MOVEMENT PROFILE. THE FETAL MOVEMENT PROFILE (FMP) PARAMETER DETECTS FETAL MOVEMENTS VIA AN ULTRASOUND TRANSDUCER CONNECTED TO THE MONITOR. ONLY THE FETUS MONITORED ON THE FHR1 CHANNEL IS MONITORED FOR FMP. ONCE YOU HAVE ENABLED FMP, IT IS TRIGGERED AUTOMATICALLY WHENEVER: YOU CONNECT AN ULTRASOUND TRANSDUCER, A PT IS DISCHARGED. BE AWARE THAT WHEN USING AN AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM (M2720A), THE MONITOR AUTOMATICALLY SETS THE FMP TO OFF. WHEN FMP IS ENABLED, THE ULTRASOUND TRANSDUCER DETECTS GROSS FETAL BODY MOVEMENTS. EYE MOVEMENTS ARE NOT DETECTED AND MOVEMENT OF THE FEET AND HANDS MAY NOT BE DETECTED. POSITIONING OR REPOSITIONING OF THE TRANSDUCER IS RECORDED AS FETAL MOVEMENT. MATERNAL MOVEMENT, EXCESSIVE FETAL BREATHING OR FETAL HICCUPS MAY ALSO BE RECORDED AS FETAL MOVEMENT. YOU CAN MARK THESE ARTIFACTS ON THE TRACE PAPER USING EITHER THE REMOTE EVENT MARKER OR THE EVENT MARKER KEY AS DESCRIBED IN "MARKING AN EVENT." IGNORE THESE MOVEMENTS WHEN YOU INTERPRET THE FMP. WHEN MONITORING TWINS OR TRIPLETS, ONLY THE FETUS MONITORED ON THE FHR1 CHANNEL IS MONITORED FOR MOVEMENT, BUT BE AWARE THAT MOVEMENTS RECORDED FOR FHR1 MAY ALSO BE CAUSED BY MOVEMENT OF THE SECOND OR THIRD FETUS. THE FETAL MOVEMENT PROFILE (FMP) APPEARS AS "ACTIVITY BLOCKS" ALONG THE TOP OF THE TOCO SCALE, THE LENGTH OF EACH BLOCK SHOWING THE DURATION OF THE ACTIVITY. SWITCHING FMP ON AND OFF, YOU CAN SWITCH FMP ON AND OFF FROM ANY FHR CHANNEL. FOR EXAMPLE, TO SET IT FROM THE FHR1 CHANNEL: ENTER THE SETUP FHR1 MENU; SELECT FETAL MOVEMENT TO TOGGLE BETWEEN ON AND OFF; RETURN TO THE MAIN SCREEN. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DECEASED FETUS DURING MONITORING WITH AN AVALON FM30 FETAL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM30 FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death