BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 22944104 · Received September 2, 2025

    Report

    Report Number
    9610816-2025-000807
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 2, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. E1: REPORTING INSTITUTION PHONE # (B)(6). E1: REPORTER PHONE # (B)(6). A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER AND CONFIRMED THAT TRANSDUCER IS FAULTY. A NEMO (NON-ENGINEERING MATERIAL ONLY) SERVICE WAS AGREED UPON. THE CUSTOMER ORDERED A REPLACEMENT TRANSDUCER 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 THE AVALON US TRANSDUCER INDICATING THE SOUND IS INAUDIBLE. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188612 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown