BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 23547455 · Received November 13, 2025

    Report

    Report Number
    9610816-2025-001065
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 5, 2026
    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
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS INITIALLY REPORTED AGAINST THE TOCO TRANSDUCER. THE TOCO IS THE INCORRECT PRODUCT. THE REPORT IS UPDATED TO THE AVALON ULTRASOUND TRANSDUCER. D1 BRAND NAME INFORMATION IS UPDATED. D2A COMMON DEVICE NAME IS UPDATED. D2B PROCODE IS UPDATED. D4 CATALOG ITEM IDENTIFIER IS UPDATED TO 989803143691. D4 UDI IS UPDATED TO (B)(4). PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE ISSUE. A REPLACEMENT TRANSDUCER WAS SHIPPED TO THE CUSTOMER. THE CUSTOMER HAS ASSUMED THE REPAIR RESPONSIBILITY. 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

    THE CUSTOMER REPORTED THAT THE TRANSDUCER IS NOT TAKING CORRECT READINGS. THE DEVICE WAS IN CLINICAL 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
    1928653 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