BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 23827283 · Received December 17, 2025

    Report

    Report Number
    9610816-2025-001241
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 17, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    UDI-DI
    00884838002722
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) VERIFIED THE AVALON ULTRASOUND TRANSDUCER NEEDED TO BE REPLACED. THE RSE VERIFIED CUSTOMERS CONTACT AND SHIPPING INFORMATION IN THE SYSTEM IS CORRECT AND PLACED A PARTS ORDER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A FAULTY TRANSDUCER. THE REPORTED PROBLEM WAS CONFIRMED. THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED 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 AN AVALON US TRANSDUCER INDICATING THAT THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) STATED THE UNIT IS NOT MAKING ANY SOUND. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181085 AVALON US TRANSDUCER TRANSDUCER, ULTRASONIC, OBSTETRIC HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER 00884838002722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown