BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 23631521 · Received November 24, 2025

    Report

    Report Number
    9610816-2025-001113
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 18, 2025
    Report Date
    November 24, 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
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SUPPORT ENGINEER (RSE) TALKED TO THE CUSTOMER AND CONFIRMED THE TRANSDUCER GIVES INCORRECT READING AND ARRANGED FOR A REPLACEMENT TRANSDUCER TO BE SENT TO THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE REPORTED PROBLEM WAS A DEFECTIVE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ULTRASOUND TRANSDUCER SHOWS LOW MEASUREMENT. WHEN USED THE TRANSDUCER DISPLAYS A HEART RATE (HR) OF 60, HOWEVER WHEN THE CUSTOMER IS USING OTHER SENSORS, THESE GIVE A HR OF 130. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390065 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER 00884838002722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown