BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 20772784 · Received November 25, 2024

    Report

    Report Number
    9610816-2024-000902
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 9, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838000414
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. E1: (B)(6).

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER AND DISPATCHED A PHILIPS FIELD SERVICE ENGINEER (FSE) ONSITE TO CHECK THE UNIT OVER TO ENSURE THE TRANSDUCERS WERE DOCKING AS THEY SHOULD BE AND THE WIRELESS CHECKS WERE DONE, AS WELL AS, FREE OF INTERFERENCE. ONCE ONSITE, THE FSE CONDUCTED AN OBR SCAN, AND DECIDED TO CHANGE ROOM 8 FROM CHANNEL 9 TO CHANNEL 11. ROOM 7 REMAINS ON CHANNEL 8. THE FSE FOUND THE ADJUSTMENT CREATED A LARGER GAP BETWEEN RF CHANNELS, PARTICULARLY AS THE MOST AFFECTED AREAS ARE ROOM 7 AND ROOM 8. THROUGH OBSERVATION, THE FSE FOUND THE DEVICE TO BE OPERATING WITHOUT ISSUES. THE FSE LATER ON DISCOVERED A FIELD CHANGE ORDER (FCO) LINKED TO AN ISSUE WITH THE FETAL MONITOR'S BASE STATION THAT WARRANTED A SOFTWARE UPDATE FROM B.01.07 TO B.02.01. ONCE THE SOFTWARE UPDATE WAS ADMINISTERED UPON THE DEVICE, THE ISSUE WAS RESOLVED. THE UNIT RETURNED TO WORKING SPECIFICATION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FETAL HEART RATE (FHR) KEPT DROPPING OUT EVERY 10 SECONDS OR SO. WHEN IT CAME BACK, THE HEART RATE WAS HIGH AND THEN IT WOULD DROP. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786746 AVALON FM30 FETAL MONITOR AVALON FM30 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2703A 00884838000414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown