BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FETAL MONITOR FM30

    MDR report key: 22065082 · Received May 21, 2025

    Report

    Report Number
    9610816-2025-000426
    Event Type
    Death
    Date Received
    May 21, 2025
    Date of Event
    May 9, 2016
    Report Date
    March 26, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    EDITS TO D1: BRAND NAME; D2A: COMMON DEVICE NAME AND D4: MODEL#, CATALOG# TO ALIGN WITH GUDID. A CTG STRIP WAS PROVIDED THROUGH THE HPRA NOTIFICATION. THE STRIP WAS PROVIDED TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE); HOWEVER THE STRIP WAS TOO SHORT FOR A COMPREHENSIVE ANALYSIS. A LONGER STRIP WAS REQUESTED BUT WAS NOT PROVIDED. MULTIPLE GOOD FAITH EFFORT (GFE) ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. HOWEVER, WHILE THE HOSPITAL INITIALLY INDICATED THAT A CONSULTANT WOULD REVIEW THE PATIENT MEDICAL RECORDS, NO FURTHER INFORMATION OR RESPONSES HAVE BEEN RECEIVED. THE CAUSE OF THE ISSUE IS UNKNOWN. 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, (B)(6) HPRA SHARED FOUR ADDITIONAL TRACES WITH PHILIPS ON JANUARY 6, 2026. FETAL MONITOR SETTINGS: 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. A PHILIPS CLINICAL SCIENTIST PERFORMED A REVIEW OF THE STRIPS. THE STRIPS DEPICT THE PATIENT PROFILE BEGINNING AT 23:15 ON (B)(6) 2016. THERE IS A SIGNAL LOSS/FHR ARTEFACT AT ABOUT 23:40 AFTER THE PATIENT WAS STANDING AND RETURNED TO THE BED. IRREGULAR CONTRACTIONS WERE REGISTERED BY TOCO AND A VAGINAL EXAMINATION TOOK PLACE AT 23:54. THE PATIENT WAS NOT IN LABOR. BETWEEN 00:10 AND 00:21 AM ON (B)(6) 2016, THERE WERE TWO LARGE FHR DECELERATIONS, EACH OCCURRING AFTER A CONTRACTION WAS REGISTERED. THE FIRST LASTED FOR 2 MINUTES, AND THE DEEPEST WAS AT 80 BPM. THIS SLOWLY RECOVERED. THE SECOND DECELERATION LASTED FOR ONE MINUTE, THE DEEPEST WAS AT 100 BPM. FOLLOWING THE SECOND DECELERATION, A VAGINAL EXAMINATION TOOK PLACE. THE RESULT IS WRITTEN ON THE CTG: VX -3 (WHICH STATES THE CAPUT BEING ENGAGED IN THE PELVIC INLET). THE PATIENT DISPLAYED DILATION; HOWEVER, THE VALUE CANNOT BE DETERMINED FROM THE STRIP DOCUMENTATION. AT 00:45 AM CTG: MAT. (MATERNAL) PULSE 70-120 BPM, FHR: BL 155 BPM (= 15 BPM UP, AFTER DECELERATIONS), ACC. AVAILABLE, VARIABILITY OVERALL NORMAL BUT PARTLY < 5 BPM. THERE WERE TWO SMALL, SHORT DECELERATIONS UNTIL 135 BPM. FROM 00:45 -00:50 AM, THE PATIENT IS "OUT TO TOILET". THERE IS NO FETAL MONITORING; THE DEVICE IS IN STANDBY. AT 00:51 AM, FETAL MONITORING IS CONTINUED. THE FHR: WAS160 BPM WITH A TENDENCY TO BE SALTATORY. AT 00:55, THE FHR SUDDENLY DROPS TO 80 BPM. THERE IS NO RECOVERY FOR 5 MINUTES AND THEN SLOWLY, AND WITH A SALTATORY TENDENCY, THE HR REACHES 130 BPM. MATERNAL PULSE BETWEEN 80 BPM DURING FETAL BRADYCARDIA AND ASCENDING TO 140-160 BPM WHILE THE FETUS IS REACHING 130 BPM AT 1:02 AM. AT 01:02/03 AM ON (B)(6) 2016, FETAL MONITORING IS DISCONTINUED. WRITTEN ON THE STRIP: TF TO TRANSPORT CTG. NO ADDITIONAL STRIPS OR INFORMATION WERE PROVIDED. 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. SEE ATTACHED REPORT DETAILING THE FINDINGS.

    Additional Manufacturer Narrative · 0

    H6: PATIENT OUTCOME CODE GRID IS UPDATED. H6: HEALTH IMPACT CODE GRID IS UPDATED. THE POST-MORTEM REPORT WAS PROVIDED TO PHILIPS. THE REPORT INDICATES THAT THE INFANT PATIENT WAS BORN VIA PRE-LABOR C-SECTION AT 35 WEEKS AND 3 DAYS. THE INFANT DID NOT MAKE ANY RESPIRATORY EFFORT AT BIRTH. SUMMARY OF EVENTS: THE MOTHER WAS ADMITTED ON (B)(6) 2016, WITH ABDOMINAL THICKENING AFTER HAVING A ¿SHOW.¿ A VAGINAL EXAM SHOWED THE CERVIX WAS CLOSED AND MEASURED 2 TO 3 CM. THE FIRST DOSE OF BETAMETHASONE WAS ADMINISTERED, WITH A PLAN FOR A SECOND DOSE ON (B)(6) AT 15:00 HOURS. AT 23:10 ON (B)(6), THE MEMBRANES RUPTURED, SROM, AND GRADE 1 MECONIUM WAS DETECTED. THE MOTHER WAS TRANSFERRED TO THE LABOR WARD FOR CONTINUOUS MONITORING. THE FETAL HEART RATE WAS NORMAL RANGE AT 152 BPM AND THE CTG WAS WITHIN NORMAL RANGE AND REASSURING. AT 24:20 ON (B)(6), CTG SHOWED A DECELERATION, BUT IT RECOVERED. MONITORING CONTINUED. AT 01:00 ANOTHER CTG DECELERATION OCCURRED, AND THE TEAM DECIDED ON A GRADE 1 EMERGENCY C-SECTION. THE BABY WAS DELIVERED WITH THE CORD LOOSE AROUND THE NECK. MECONIUM WAS PRESENT, AND THE BABY WAS IMMEDIATELY HANDED TO THE PEDIATRIC TEAM IN THEATRE. CORD ARTERIAL PH WAS 7.250 WITH A BASE EXCESS OF -6 AND VENOUS BLOOD WAS 7.336 AND BASE EXCESS WAS -1.3. THE PLACENTA WAS DELIVERED AND SENT FOR HISTOLOGY. THE BABY REQUIRED RESUSCITATION AT BIRTH AND WAS TRANSFERRED FOR FURTHER CARE AND LATER PASSED AWAY. BASED ON THE HOSPITAL¿S GOOD FAITH EFFORT RESPONSE, THE PHYSICIAN DOES NOT BELIEVE THE DEVICE WAS RELATED TO THE INFANT DEATH. THE POST-MORTEM REPORT STATES THE CAUSE OF DEATH AS PULMONARY HYPERTENSION CAUSED BY SYSTEMIC THROMBOSIS, WITH A NON-LETHAL MITOCHONDRIAL DISORDER NOTED AS A CONTRIBUTING FACTOR. FIELD SAFETY NOTICE FSN86201075. PHILIPS ISSUED FIELD SAFETY NOTIFICATION FSN86201075 ON 20 NOVEMBER 2009.A PHILIPS SENIOR RESEARCH AND DEVELOPMENT MANAGER REVIEWED THE SERIAL NUMBERS OF THE DEVICES IN USE DURING THE MOTHER'S HOSPITAL STAY ON (B)(6) 2016 AND (B)(6) 2016 IN RELATION TO FSN86201075. PHILIPS CONFIRMS THAT THE MONITORING EQUIPMENT IN QUESTION WAS NOT WITHIN THE SCOPE OF FSN86201075. THE REQUIRED ACTIONS UNDER THE FSN HAD ALREADY BEEN IMPLEMENTED ON THOSE UNITS, OR THE EQUIPMENT WAS ACQUIRED AFTER THE FSN WAS RELEASED. ALL SOFTWARE, FIRMWARE, AND INSTRUCTIONS FOR USE WERE CURRENT AT THE TIME OF USE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT A PHILIPS DEVICE CAUSED OR CONTRIBUTED TO THE INFANT DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED FOLLOWING AN INFANT DEATH, THE MOTHER REPORTED CONCERNS RELATED TO PREVIOUS RECALLS RELATED TO THE DEVICE. IT WAS INDICATED THE EVENT OCCURRED IN 2016. 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
    884836 AVALON FETAL MONITOR FM30 SYSTEM, MONITORING, PERINATAL HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM30

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Male Death