BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FETAL MONITOR FM30

    MDR report key: 22662383 · Received July 30, 2025

    Report

    Report Number
    9610816-2025-000677
    Event Type
    Death
    Date Received
    July 30, 2025
    Date of Event
    December 27, 2021
    Report Date
    February 25, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE GOOD FAITH EFFORTS ATTEMPTS HAVE BEEN CONDUCTED TO GATHER MORE INFORMATION BUT HAVE BEEN UNSUCCESSFUL. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM IS UNKNOWN. THE REPORTED PROBLEM WAS NOT CONFIRMED. WE ARE UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE, BECAUSE THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. WITH THE PATIENT'S PERMISSION, IRELAND HPRA SHARED 11 ADDITIONAL TRACES WITH PHILIPS ON DECEMBER 12TH2025. FETAL MONITOR SETTINGS: THE CTG STRIPS WERE SENT TO A PHILIPS CLINICAL SCIENTIST SPECIALIST WHO REVIEWED THEM AND GAVE THEIR FINDINGS ON 09JAN2025. A PHILIPS CLINICAL SCIENTIST PERFORMED A REVIEW OF THE STRIPS. FETAL HEAT RATE (FHR1) ALARM SETTING 110/160, MATERNAL PULSE MEASURED BY SPO2 FINGER SENSOR, CONTRACTIONS MEASURED BY TOCO, FETAL MOVEMENT PROFILE (FMP) ACTIVE, SPEED 1CM/MINUTE, CROSS CHANNEL VERIFICATION (CCV) AVAILABLE. THE STRIPS DEPICT THE PATIENT PROFILE BEGINNING AT 01:45 THROUGH 19:16 ON (B)(6) 2021. THE FETAL MONITOR: FHR ALARMING ACTIVE 110/160 BPM, PULSE ALARMING ACTIVE 50/120 BPM, CCV AVAILABLE, CONTRACTIONS BY TOCO+MP, MATERNAL PULSE BY SPO2, FMP ACTIVE. SPEED 1CM/1 MINUTE. ON (B)(6) 2021, THE PATIENT WAS 39+5 WEEKS PREGNANT AND STATED HER WATER BROKE THAT DAY AROUND 00:45 AM. THE PATIENT WENT TO THE HOSPITAL. THE CTG MONITORING STARTED AT ABOUT 01:45 AM. WHERE THE FETAL MONITOR: FHR ALARMING ACTIVE 110/160 BPM, PULSE ALARMING ACTIVE 50/120 BPM, CCV AVAILABLE, CONTRACTIONS BY TOCO+MP, MATERNAL PULSE BY SPO2, FMP ACTIVE. SPEED 1CM/1 MINUTE. THE CTG: BASELINE ~155 BPM, ACCELERATIONS AVAILABLE, VARIABILITY =/> 5 BPM (NORMAL), NO DECELERATIONS. CONTRACTIONS: IRREGULAR, EVERY 2 - 10 MINUTES. MATERNAL PULSE: 90 ¿ 120 BPM ANOTHER CTG MONITORING WAS PERFORMED IN THE MORNING UNTIL NOON. A DOPPLER TEST WAS PERFORMED BETWEEN 02:30 PM AND 03:00 PM. ON (B)(6) 2021, CTG 11:15 AM ¿ 12:05 PM, THE BASELINE ~ 150 BPM, ACCELERATIONS AVAILABLE, VARIABILITY =/> 5 BPM (NORMAL), NO DECELERATIONS. CONTRACTIONS: IRREGULAR. MATERNAL PULSE: 90 ¿ 120 BPM. ON (B)(6) 2021 CTG 07:00 PM ¿ 07:16, THE CCV ALARMING 3 TIMES. FHR AND MATERNAL PULSE ARE SIMILAR, SHOWING A PULSE BETWEEN 110 AND 150 BPM. AT 07:16 PM MONITORING IS STOPPED. THE INVESTIGATION DETERMINED THAT THERE WAS NO MALFUNCTION OF THE PHILIPS AVALON FM30 FETAL MONITOR OR THE TOCO TRANSDUCER. THE DEVICES WERE PERFORMING AS EXPECTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED FROM THE HOSPITAL QUALITY & PATIENT SAFETY DEPARTMENT REPRESENTATIVE, IT STATED THAT THE CAUSE OF DEATH WAS LISTED AS RETRO-PLACENTAL HEMORRHAGE AND ANTENATAL ANOXIA. IT WAS CLARIFIED THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, AND THE PHYSICIAN DID NOT BELIEVE THAT THE DEVICE OR ITS BEHAVIOR CONTRIBUTED TO THE PATIENT'S DEATH, AND THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. THE REPORTER'S NAME AND EMAIL WERE PROVIDED; HOWEVER, DUE TO PRIVACY LAWS WERE NOT INCLUDED IN THE REPORT. E1 REPORTER PHONE#: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MONITOR MEASURED THE MATERNAL HEART RATE INSTEAD OF THE FETAL HEART RATE ON TWO SEPARATE CTG READINGS AND THE FETUS WAS STILLBORN AT TERM. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48858 AVALON FETAL MONITOR FM30 SYSTEM, MONITORING, PERINATAL HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death