BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19435098 · Received May 31, 2024

    Report

    Report Number
    9610816-2024-00297
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    April 24, 2024
    Report Date
    August 22, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838093195
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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 VV-B300-2024-00172, AND DETERMINED THAT THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER ENGINEERING CHANGE B300-2023-02-30892, 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. THE FCO HAS BEEN IMPLEMENTED, THE ISSUE WAS RESOLVED AFTER UPDATING THE TRANSDUCER FIRMWARE.

    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.

    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". IT WAS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT AND NO ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT SYSTEM IS CONTINUES TO DISPLAY VALUES THAT ARE TOO HIGH WITH THE FETAL HEART FREQUENCY 180BPM. 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
    299304 AVALON US TRANSDUCER AVALON US TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown