BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FETAL MONITOR FM50

    MDR report key: 22978131 · Received September 5, 2025

    Report

    Report Number
    9610816-2025-000816
    Event Type
    Death
    Date Received
    September 5, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 19, 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
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A GOOD FAITH EFFORT (GFE) WAS MADE TO GET ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT THE CUSTOMER DID NOT SHARE ANY MORE INFORMATION. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND WAS UNABLE TO CONFIRM CAUSE OF THE REPORTED TRACING DROPOUTS. THE CUSTOMER DECIDED TO USE ONLY HARDWIRE TRANSDUCERS AS THERE SEEMED TO BE SOME SORT OF INTERMITTENT OUTSIDE INTERFERENCE THAT COULD NOT BE DETERMINED. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT MALFUNCTION WAS UNABLE TO BE CONFIRMED. AS FOR PRECAUTIONARY MEASURES THE OBR CHANNELS WERE CHANGED, AND THE CUSTOMER SWITCHED TO HARDWIRE TRANSDUCERS AND WAS INFORMED TO CALL BACK IF THE ISSUE STILL PERSISTS. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TRACINGS GENERATED VIA THE WIRELESS TRANSDUCER INTERMITTENTLY DROPPED OUT WHILE FETAL DECELERATIONS WERE OCCURRING, WHICH RESULTED IN THE PATIENT BEING TRANSPORTED TO ANOTHER HOSPITAL; HOWEVER, THE CUSTOMER INDICATED THEY DID NOT BELIEVE THE MONITOR ISSUE CONTRIBUTED TO THE PATIENT CONDITION. THE STAFF CHANGED TO WIRELESS MONITORING DUE TO THIS ISSUE AND INDICATED THIS LABOR AND DELIVERY ROOM IS THE ONLY ROOM EXPERIENCING THIS ISSUE. IT WAS ALSO NOTED THE HOSPITAL USES GE CENTRICITY FOR CENTRAL MONITORING. BASED ON THIS INFORMATION, THE FETUS EXHIBITED DECELERATIONS WHILE THERE WERE SIGNAL DROPOUTS, WHICH THE CUSTOMER DOES NOT BELIEVE WAS DUE TO THE DROPOUTS; HOWEVER, THE TYPE OF REPORTED COMPLAINT WAS MARKED AS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975688 AVALON FETAL MONITOR FM50 AVALON FETAL MONITOR FM50 HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR 00884838000438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death