BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19419491 · Received May 29, 2024

    Report

    Report Number
    9610816-2024-00288
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    December 27, 2023
    Report Date
    September 11, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    PMA / PMN Number
    K140535
    Removal / Correction Number
    Z-2239-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A DESIGN DEFECT IN THE TRANSDUCER'S FIRMWARE (FW). PHILIPS INVESTIGATION DETERMINED THIS ISSUE IS CAUSED BY CHANGES IMPLEMENTED UNDER AN ENGINEERING CHANGE RELEASED MAY 25,2023. THESE CHANGES UPDATED THE ULTRASOUND T=TRANSDUCER WITH A NEW CENTRAL PROCESSING UNIT (CPU) BOARD AND FIRMWARE IN RESPONSE TO A SHORTAGE OF MULTIPLE COMPONENTS. DUE TO A CHIP SHORTAGE SITUATION, A HARDWARE (HW)/SOFTWARE (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 CUSTOMER WILL RECEIVE THE FIELD CHANGE ORDER UPDATE AT A FUTURE DATE. THE CUSTOMER HAS BEEN NOTIFIED OF THIS ISSUE AND THE FIRMWARE WILL BE UPDATED IN THE FUTURE. 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

    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 A BEAT SEEMS TO JUMP TO 180 VERY INTERMITTENTLY. THE STAFF IS MONITORING TWINS AND SEES NO ISSUE WITH THE BABY. THE INITIAL INVESTIGATION FOCUSED ON THE PRODUCT HARDWARE AND A SOCKET CONNECTOR BLOCK WAS SENT TO THE CUSTOMER. 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
    1884057 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown