BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVUE 850

    MDR report key: 20137321 · Received September 4, 2024

    Report

    Report Number
    3019216-2024-00129
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 30, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838097711
    PMA / PMN Number
    K153480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. THE TRANSDUCER WAS RETURNED FOR A PART EVALUATION, AND IT WAS FOUND THE TRANSDUCER FAILED THE DIELECTRIC STRENGTH AND LEAKAGE TESTING DUE TO SEVERE GOUGES IN THE FACE OF THE TRANSDUCER. THE GOUGES ARE LOCATED WHERE THE TRANSDUCER WAS FAILING THE TESTING. BASED ON PRIOR OBSERVATIONS, THE SHAPE AND PATTERN OF THE GOUGES AND IMPACT MARKS ON THE LENS, IT WAS DETERMINED THAT CAUSE WAS IMPACT FROM A GEL BOTTLE TO THE LENS OF THE TRANSDUCER. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE USER FELT OCCASIONAL ELECTRICAL LEAKAGE FROM THE C5-2 TRANSDUCER. THE USER REPORTED SENSING A LEAK AND HAVING NUMBNESS, BUT NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER REPORTED THE TRANSDUCER PASSES THE LEAKAGE TEST. THE CUSTOMER¿S IMMEDIATE CONCERNS WERE ADDRESSED BY REPLACING THE TRANSDUCER. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700608 CLEARVUE 850 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC CLEARVUE 850 DIAG ULTRASOUND SYS 00884838097711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown