BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19542636 · Received June 14, 2024

    Report

    Report Number
    9610816-2024-00332
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 3, 2024
    Report Date
    August 13, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838093195
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT "DURING MONITORING A TWIN PREGNANCY, FHR AROUND 180 BPM WHICH WAS INCORRECT, AND LED TO AN UNNECESSARY C-SECTION THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: PER THE CUSTOMER, IT WAS INDICATED THE MOTHER WAS AT 39 WEEKS GESTATION AND PRESENTED FOR INDUCTION. WHILE MONITORING, ONE TWIN HEART RATE WAS AROUND 170 BPM AND THE OTHER WAS 120 BPM, A C-SECTION WAS PERFORMED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. A GOOD FAITH EFFORT (GFE) STATES THAT THE STATUS OF THE BABY WAS DESCRIBED AS GOOD. ULTRASOUND TRANSDUCERS WITH SOFTWARE VERSION L.01.04 WERE REMOVED FROM THE HOSPITAL WARD PER THE LETTER FROM PHILIPS THE ISSUE OCCURRED WHEN MONITORING TWINS WITH WIRED US TRANSDUCER WITH 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 (B)(6) 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 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 BASED ON THE INFORMATION PROVIDED IN THE CASE AND THE TESTS CONDUCTED, THE FCO 86202016A HAS BEEN IMPLEMENTED. THE AVALON US TRANSDUCER WITH FW. L.01.04 WAS UPDATED TO THE TRANSDUCER FW REV. L.01.05. CUSTOMER CONFIRMED VIA GOOD FAITH EFFORTS (GFE) THAT THE FCO WAS IMPLEMENTED ON (B)(6) 2024. THE ISSUE WAS RESOLVED WITH THE UPGRADE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    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. ------------------------------------------------------------------- REPORTING INSTITUTION PHONE NUMBER:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE MONITORING A TWIN PREGNANCY WITH THE ULTRASOUND TRANSDUCER, THE MONITOR DISPLAYED A HEART RATE AROUND 180BPM, WHICH WAS INCORRECT, AND LED TO AN UNNECESSARY C-SECTION. THE STATUS OF THE BABY WAS DESCRIBED AS GOOD. ULTRASOUND TRANSDUCERS WITH SOFTWARE VERSION L.01.04 WERE REMOVED FROM THE HOSPITAL WARD PER THE LETTER FROM PHILIPS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939442 AVALON US TRANSDUCER AVALON US TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246 00884838093195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other