BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON ULTRASOUND TRANSDUCER USA

    MDR report key: 23200784 · Received October 2, 2025

    Report

    Report Number
    9610816-2025-000905
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 2, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: PRODUCT UDI - THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016, THEREFORE NO UDI. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE CUSTOMER RECEIVED TROUBLE SHOOTING ASSISTANCE FROM A REMOTE SUPPORT ENGINEER (RSE) AND IT WAS CONFIRMED THAT THE DEVICE IS NOT COMMUNICATING AS DESIRED. TRANSDUCER (WHEN WORKING) IS INACCURATE AND INTERMITTENTLY DOES NOT COMMUNICATE. CUSTOMER REQUESTED A QUOTE FOR REPLACEMENT. THE CUSTOMER RECEIVED A QUOTE FOR A REPLACEMENT. CUSTOMER IS TAKING RESPONSIBILITY FOR ORDERING AND REPAIRING THE DEVICE. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS NOT COMMUNICATING. THE REPORTED PROBLEM WAS CONFIRMED. THE CUSTOMER WAS PROVIDED WITH INFORMATION ON PART. THE CUSTOMER IS TAKING RESPONSIBILITY TO REPAIR THE DEVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER (USA) INDICATING THAT THE TRANSDUCER IS INACCURATE AND INTERMITTENTLY INOPERATIVE. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313076 AVALON ULTRASOUND TRANSDUCER USA TRANSDUCER, ULTRASONIC, OBSTETRIC HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown