BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19434485 · Received May 31, 2024

    Report

    Report Number
    9610816-2024-00294
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    April 24, 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
    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 THERE WAS AN INACCURATE FETAL HEART RATE (FHR) PRODUCED WHEN MONITORING TWINS USING ULTRASOUND (US) TRANSDUCER WITH FIRMWARE (FW) VERSION L.01.04. THE COMPLAINT WAS ESCALATED FOR ISSUE IMPACT ASSESSMENT (IIA) AND DETERMINED THAT THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER ENGINEERING CHANGE B300-2023-02-30892, RELEASED (B)(6) 2023. THESE CHANGES UPDATED THE ULTRASOUND TRANSDUCER WITH A NEW CPU BOARD AND FW 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 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 FW (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 US TRANSDUCERS (PRODUCT NO. 867246) HAVE A TENDENCY TO PRODUCE AN ARTIFICIAL 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 FW. THE REPORTED PROBLEM WAS CONFIRMED. THE RSE PROVIDED A REPLACEMENT TRANSDUCER UNDER PARTS WARRANTY TO THE CUSTOMER SITE, BECAUSE THE SYSTEM WAS OUT OF USE UNTIL THE FIELD CHANGE ORDER (FCO) WAS IMPLEMENTED. THE FCO HAS BEEN IMPLEMENTED, AND THE ISSUE WAS RESOLVED AFTER UPDATING THE TRANSDUCER FIRMWARE.

    Additional Manufacturer Narrative · 0

    (B)(6) . 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

    IT WAS REPORTED THAT THE SYSTEM CONTINUES TO DISPLAY VALUES THAT ARE TOO HIGH WITH THE FETAL HEART FREQUENCY 180BPM. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM CONTINUES TO DISPLAY VALUES THAT ARE TOO HIGH WITH THE FETAL HEART FREQUENCY 180BPM. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331206 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown