BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19336745 · Received May 16, 2024

    Report

    Report Number
    9610816-2024-00271
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    May 7, 2024
    Report Date
    August 21, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE REPORTED ISSUE THAT "INACCURATE FHR (FETAL HEART RATE) WERE PRODUCED WHEN MONITORING TWINS". THE ISSUE OCCURRED WHEN MONITORING TWINS WITH WIRED ULTRASOUND (US) TRANSDUCER WITH FIRMWARE REVISION L.01.04. THE COMPLAINT WAS ESCALATED FOR AN ISSUE IMPACT ASSESSMENT. PHILIPS INVESTIGATED THE COMPLAINT AND DETERMINED THAT THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER AN ENGINEERING CHANGE RELEASED ON MAY 25 2023. 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 HARDWARE/SOFTWARE DESIGN CHANGE WAS REQUIRED, WHICH INTRODUCED A PERFORMANCE ISSUE TO THE (FHR) MEASUREMENT OF WIRED 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 REVISION 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 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. A FIELD CHANGE ORDER (FCO) HAS BEEN IMPLEMENTED, AND THE ISSUE WAS RESOLVED AFTER UPDATING THE TRANSDUCER FIRMWARE. 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

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTING INFORMATION: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FETAL HEART RATE WAS TOO HIGH ON THE ULTRA-SOUND (US) SENSOR. THE CUSTOMER DESCRIBED AN HF FREQUENCY OF 180 BEATS PER MINUTE (BPM) IN TEST MODE; THIS MESSAGE ALSO CAME FROM THE DELIVERY ROOM DURING TWIN MONITORING. AS AN EXPERIMENT, PHILIPS REPLACED ONE OF THE AFFECTED SENSORS, WHICH, ACCORDING TO THE CUSTOMER, SHOWED THE SAME BEHAVIOR. THE DEVICE WAS IN CLINICAL USE A THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439051 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female