BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 20834605 · Received December 3, 2024

    Report

    Report Number
    9610816-2024-000929
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 13, 2024
    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

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE FIELDS SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE IN QUESTION. IT WAS STATED THE SYSTEM HAS BEEN EXPERIENCING INTERMITTENT DROPOUTS. THE CUSTOMER THE WI-FI WAS RECENTLY UPDATED, WHICH MIGHT SUGGEST ENVIRONMENTAL INTERFERENCE AS A POTENTIAL CAUSE. DUE TO THE ROOM BEING OCCUPIED AND THE PATIENT ACTIVELY IN LABOR, I WAS UNABLE TO ACCESS THE DEVICE FOR AN EXTENDED PERIOD. HOWEVER, FROM MY OBSERVATIONS, THE DEVICE APPEARED TO BE OPERATING WITHOUT ISSUES. WITH THAT THE FSE CHANGED THE SETTINGS AFTER CONDUCTING AN OBR SCAN, THE FSE CHANGE ROOM 8 FROM CHANNEL 9 TO CHANNEL 11. ROOM 7 REMAINS ON CHANNEL 8. THIS ADJUSTMENT CREATES A LARGER GAP BETWEEN RF CHANNELS, PARTICULARLY AS THE MOST AFFECTED AREAS ARE ROOM 7 AND ROOM 8. THIS INFORMATION WAS GIVEN TO THE CUSTOMER AND REQUESTED MONITORING OF THE DEVICE OVER A PERIOD OF TIME TO DETERMINE IF THE ISSUE PERSISTS. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    E1; REPORTER INSTITUTION PHONE NUMBER (B)(6). E1: REPORTER PHONE NUMBER: (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE FETAL MONITORING IS LOSING TRANSDUCER SIGNAL APPROXIMATELY EVERY TEN SECONDS AND WHEN IT CAME BACK THE HEART RATE WAS HIGH AND THEN WOULD DROP. THE USER SWAPPED THE US TRANSDUCERS AS THE SIGNAL WAS NOT PICKING UP; HOWEVER, EVEN THOUGH THE US TRANSDUCER WAS DOCKED, THE FM30 WAS STILL PICKING IT UP AND HAD NOT REMOVED IT FROM SCREEN. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414214 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