BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FETAL MONITOR FM50

    MDR report key: 21734289 · Received March 31, 2025

    Report

    Report Number
    9610816-2025-000260
    Event Type
    Death
    Date Received
    March 31, 2025
    Date of Event
    January 31, 2025
    Report Date
    June 20, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838000438
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE, AND THE DEVICE PASSED OPERATING AND PERFORMANCE TESTS. THE FSE RECOVERED THE INTERNAL LOGS OF THE DEVICE FOR ANALYSIS. THE PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SECTION E REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND THE CHRONOLOGY OF THE EVENT WAS REVIEWED BY A CLINICAL SCIENTIST. IT WAS INDICATED THE MOTHER AT 37+4 WEEKS GESTATION WITH A NORMAL PREGNANCY PRESENTED DUE TO BROKEN WATER WITH REGULAR CONTRACTIONS. THE APGAR OF THE BABY AT BIRTH WAS 0/0/0. DURING THE COURSE OF LABOR, VISUAL AND AUDIBLE ALARMS WERE PRESENT FOR TACHYCARDIA, BRADYCARDIA, AND COINCIDENCE OR CROSS-CHANNEL VERIFICATION (CCV) PARAMETERS. BASED ON THE CHRONOLOGY PROVIDED, THE DOCUMENTATION DOES NOT DESCRIBE ACKNOWLEDGEMENT/HANDLING OF ALARMS. IT WAS DOCUMENTED THAT FHR WAS DIFFICULT TO FIND AT TIMES. AT 1900, THE WIRELESS TRANSDUCER WAS EXCHANGED FOR A WIRED TRANSDUCER; HOWEVER, THE TOCO + MATERNAL PULSE (MP) TRANSDUCER WAS NOT APPLIED FROM 1910-1946; THEREFORE, THE CCV FUNCTIONALITY WOULD NOT ALARM DURING THIS TIME PERIOD DUE TO NO MATERNAL INPUT AND OTHER MEANS OF MEASURING MATERNAL PULSE WERE NOT DESCRIBED IN THE DOCUMENTATION. IT REMAINED UNCLEAR IF THE STAFF WAS WORKING WITH THE FM50 MONITOR OR THE NON-PHILIPS CENTRAL MONITOR DURING LABOR. AT 1946, THE TOCO +MP WAS APPLIED WITH TRACES OF 80-95 BPM REGISTERED THREE TIMES DURING A PERIOD OF ONE MINUTE EACH BY THE TRANSDUCER. IT COULD NOT BE CONCLUDED THIS HEART RATE WAS FHR SINCE THE MATERNAL PULSE HAD BEEN >100BPM SINCE FETAL MONITORING STARTED. CCV ALARMS WERE ACTIVATED AT ONE POINT. ADDITIONAL CHRONOLOGY WAS REVIEWED BY THE CLINICAL SCIENTIST THROUGH THE TIME OF BIRTH WAS NOTED. THE CONCLUSION IS AS FOLLOWS: "THE CTG-RECORDINGS OF THE AVALON FM 50 RAN FOR APPROXIMATELY 4 HOURS. COINCIDENCE ALARMING AND BRADYCARDIA ALARMING WERE ACTIVE AND REGULARLY TRIGGERED. THE AVAILABLE DOCUMENTATION AND INFORMATION SHOW THAT THERE WAS SOME DIFFICULTY IN DERIVING THE FHR, ESPECIALLY WHEN THE WOMAN IN LABOR WAS MOBILE AND IN AN ¿ALL FOURS¿ POSITION. HOWEVER, NO EVIDENCE IS AVAILABLE FROM THE PROVIDED SOURCES, THAT A COUNTERCHECK OF THE MATERNAL PULSE HAS BEEN PERFORMED. BY THE RECORDINGS OF THE FETAL MONITOR, IT WAS CONFIRMED THAT NO SPO2 FINGER SENSOR NOR A MATERNAL ELECTROCARDIOGRAM (MECG) HAS BEEN USED. ACCORDING TO THE INFORMATION PROVIDED BY THE HOSPITAL, DURING THE PERIOD OF CCV ALARMING, AN OBSTETRIC SONOGRAPHY OF THE FETAL CONDITION HAS NOT BEEN PERFORMED. THERE IS NO EVIDENCE THAT A COUNTERCHECK OF THE MATERNAL PULSE BY MANUAL DETERMINATION OF THE MATERNAL PULSE WAS COMPARED WITH THE FETAL HEART RATE SOUND SIGNALS FROM THE US TRANSDUCER. THE REGISTERED MATERNAL PULSE OF THE WOMAN IN LABOR WAS MAINLY ABOVE 110 BPM AND THEREFORE CAUSING CCVS ON A REGULAR BASIS IF THE TOCO+MP TRANSDUCER WAS APPLIED, WHICH HAS NOT BEEN THE CASE DURING ABOUT 50 MINUTES IN TOTAL. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE DEVICE WAS PROVIDING COINCIDENCE AND OTHER ALARMS THROUGHOUT THE COURSE OF LABOR. THERE WAS NO ISSUE FOUND WITH THE DEVICE. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS BORN WITH SEVERE ACIDOSIS AND CARED FOR IMMEDIATELY BUT PASSED AWAY AFTER 55 MINUTES. THE USER THOUGHT THE PROBLEM MAY HAVE BEEN THAT THE DEVICE SWITCHED THE FETAL AND MATERNAL PULSE ON THE PRINTED TRACE. THE DEVICE REMAINS IN USE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM50 FETAL MONITOR INDICATING THAT A PATIENT WAS BORN WITH SEVERE ACIDOSIS AND CARED FOR IMMEDIATELY BUT PASSED AWAY AFTER 55 MINUTES. THE USER THOUGHT THE PROBLEM MAY HAVE BEEN THAT THE DEVICE SWITCHED THE FETAL AND MATERNAL PULSE ON THE PRINTED TRACE. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT 10:59 DUE TO LOSS OF AMNIOTIC FLUID AND REGULAR CONTRACTIONS, WITH FETAL MOVEMENT AND FETAL HEART RATE (FHR) PRESENT. FHR WAS MONITORED THROUGH 14:30 WHEN THE PATIENT TOOK A BATH UNTIL 16:35 WITHOUT FETAL MONITORING. AT 16:45, THE FHR WAS AGAIN MONITORED WITH A FHR AT 120 BPM. AT 17:45, THE FHR WAS IN THE 140S WITH LATE DECELERATIONS AT 100BPM, AND AT 18:45, THE FHR WAS 'NOT WELL CAPTURED' DUE TO PATIENT MOVEMENT, WITH FHR AT 140 BPM AND VARIABLE DECELERATIONS TO 100BPM. AT 18:55, THE FHR WAS NOT PICKED UP AND A SENSOR WIRE WAS IMPLEMENTED AT 19:00, WITH FHR AT 140BPM. AT 19:55, IT WAS INDICATED THE FHR WAS ¿NOT WELL CAPTURED¿ AND THE BABY WAS DELIVERED AT 20:05 WITH APGARS AT 0/0/0. RESUSCITATION WAS ATTEMPTED THROUGH 21:45, BUT DEATH WAS DECLARED DUE TO THE TOTAL ABSENCE OF SPONTANEOUS CARDIAC ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913512 AVALON FETAL MONITOR FM50 AVALON FM50 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR 00884838000438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death