BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 21395613 · Received February 18, 2025

    Report

    Report Number
    9610816-2025-000107
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 17, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    UDI-DI
    00884838093195
    PMA / PMN Number
    K140535
    Removal / Correction Number
    Z-2239-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RSE CONTACTED THE CUSTOMER AND CONFIRMED THE REPORTED ISSUE OF INACCURATE FHR (FETAL HEART RATE) BEING PRODUCED WHEN MONITORING MULTIPLE FETUSES. THE ISSUE OCCURRED WHEN MONITORING WITH A WIRED US TRANSDUCER WITH FIRMWARE (FW) L.01.04. PHILIPS INVESTIGATED THESE COMPLAINTS, DOCUMENTED UNDER (B)(4), AND DETERMINED THAT THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER ENGINEERING CHANGE (B)(4), RELEASED 25MAY2023. THESE CHANGES UPDATED THE ULTRASOUND TRANSDUCER WITH A NEW CPU BOARD AND FIRMWARE IN RESPONSE TO A SHORTAGE OF MULTIPLE COMPONENTS. DUE TO A CHIP SHORTAGE SITUATION, A HW/SW DESIGN CHANGE WAS REQUIRED, WHICH INTRODUCED A PERFORMANCE ISSUE TO THE FETAL HEART RATE (FHR) MEASUREMENT OF WIRED ULTRASOUND (US) TRANSDUCERS. THE NEED FOR SUBTLE ADJUSTMENTS OF THE TRANSMIT/RECEIVE TIME WINDOWS IN US MEASUREMENTS UNEXPECTEDLY INTRODUCED INTERFERENCE WITH ADJACENT TRANSDUCERS (TWIN/TRIPLET USE CASES) BY GENERATING MEASURABLE ARTIFICIAL RHYTHMIC SIGNALS THAT CAN BE INTERPRETED AS ACTUAL PHYSIOLOGICAL SIGNALS (FETAL HEART BEATS). THIS INVESTIGATION DETERMINED THAT THE NEW FIRMWARE (453564254621-S-FW-01, REV L.01.04) WHICH IS DESIGNED FOR ALL AVALON TRANSDUCERS, SHOWS AN UNEXPECTED ISSUE FOR THE ULTRASOUND TRANSDUCER (867246). WHEN MONITORING MULTIPLES (TWINS OR TRIPLETS), THE WIRED AVALON ULTRASOUND TRANSDUCERS (PRODUCT NO. 867246) HAVE A TENDENCY TO PRODUCE AN ARTIFICIAL FETAL HEART RATE (FHR) INSTEAD OF FHR GAPS, MOSTLY AT APPROXIMATELY 180 BPM, IN SITUATIONS WHERE THE PHYSIOLOGICAL SIGNAL (ECHO FROM PULSATING FETAL HEART) IS ABSENT OR VERY WEAK. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DESIGN DEFECT IN THE TRANSDUCER'S FIRMWARE. THE REPORTED PROBLEM WAS CONFIRMED. THE FCO HAS BEEN IMPLEMENTED; THE ISSUE WAS RESOLVED AFTER UPDATING THE TRANSDUCER FW TO REV. L.01.05. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. BOX E: REPORTING INSTITUTION PHONE #: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WERE INACCURATE FETAL HEART RATE (FHR) MEASUREMENTS WHEN MONITORING MULTIPLE FETUSES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162259 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female