BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 23327591 · Received October 17, 2025

    Report

    Report Number
    9610816-2025-000966
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 24, 2025
    Report Date
    May 21, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    UDI-DI
    00884838002722
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A PHILIPS REPRESENTATIVE EVALUATED THE WIRED ULTRASOUND TRANSDUCER AND DETERMINED THAT, BY DESIGN, THE AVALON FM DOES NOT DELIVER SUFFICIENT ELECTRICAL POWER FOR A TRANSDUCER TO HEAT UP ENOUGH TO CAUSE BURNS. THE TRANSDUCER SHOWED NO SIGNS OF DEFORMATION OR DISCOLORATION AND HAS NEVER BEEN EXCESSIVELY HOT. THE ALLEGED "BURNS" WERE CONCLUDED TO BE SKIN IRRITATION OR CHEMICAL BURNS CAUSED BY CLEANING AND DISINFECTION RESIDUES LEFT ON THE PRODUCT. IT WAS ALSO FOUND THAT THE TRANSDUCER HAD BEEN SUBJECT TO UNAUTHORIZED REPAIR, USING NON-PHILIPS PARTS FOR THE HOUSING AND CABLE, AND IS THEREFORE NOT A PHILIPS PRODUCT ANYMORE. THE PARTS IN THE CUSTOMER-PROVIDED PRODUCT MAY OR MAY NOT BE FROM THE GENUINE PHILIPS M2736A. THE FINDINGS OF UNAUTHORIZED REPAIR ARE MOST LIKELY NOT RELATED TO THE CUSTOMER¿S ALLEGATIONS IN THE COMPLAINT. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. 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

    IT WAS REPORTED THE TRANSDUCER BECAME HOT AND LEFT SMALL CIRCULAR RED MARKS ON THE PATIENT, SIMILAR TO A BURN. THIS ISSUE DID NOT IMPACT PATIENT CARE OR CLINICAL WORKFLOW. THE TRANSDUCER WAS VISUALLY INSPECTED AND TESTED, REVEALING NO VISIBLE DAMAGE AND NO SIGNIFICANT TEMPERATURE INCREASE, WITH AND WITHOUT ULTRASOUND GEL. THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18802 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER 00884838002722

    Patients

    Seq Age Sex Outcome Treatment
    1