BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19404304 · Received May 28, 2024

    Report

    Report Number
    9610816-2024-00284
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 19, 2024
    Report Date
    October 1, 2024
    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
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS IS IN REFERENCE TO IIA-B300-2024-514 REV. A

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE REPORTED ISSUE THAT "SYSTEM CONTINUES TO SHOW TOO HIGH VALUES FOR FETAL HEART RATES 180BPM". THE ISSUE OCCURRED WHEN MONITORING TWINS WITH WIRED US TRANSDUCER WITH FW. L.01.04. THE COMPLAINT WAS ESCALATED FOR ISSUE IMPACT ASSESSMENT (IIA) AND THE RESULTS INDICATE " PHILIPS INVESTIGATED THESE COMPLAINTS, DOCUMENTED UNDER (B)(4), AND DETERMINED THAT THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER ENGINEERING CHANGE (B)(4), RELEASED ON 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 ((B)(4), 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. THE FCO HAS BEEN IMPLEMENTED, THE ISSUE WAS RESOLVED AFTER UPDATING THE TRANSDUCER FIRMWARE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE TRANSDUCER COULD NOT FIND OR KEEP A FETAL HEART RATE ON TWINS.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT "SYSTEM CONTINUES TO SHOW TOO HIGH VALUES FOR FETAL HEART RATES 180BPM". THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT AND NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657475 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female