BEUDAMED
    FDA Adverse Event Other Summary report: N

    C60/5-2 MHZ TRANSDUCER

    MDR report key: 2844980 · Received November 12, 2012

    Report

    Report Number
    3032367-2012-00002
    Event Type
    Other
    Date Received
    November 12, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Product Code
    IYN
    PMA / PMN Number
    K030949
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING TESTING, IT WAS CONFIRMED THAT THE EXPOSED WIRES WERE THE CAUSE OF THE REPORTED ISSUE. FUJIFILM SONOSITE, INC. CONCLUDES THIS TO BE A USER ERROR AS THE WARNINGS ON THE PRODUCT USER GUIDE CLEARLY STATES "TO AVOID THE RISK OF ELECTRICAL SHOCK, BEFORE USING THE TRANSDUCER, INSPECT THE TRANSDUCER FACE, HOUSING, AND CABLE. DO NOT USE THE TRANSDUCER IF THE TRANSDUCER OR CABLE IS DAMAGED." THE USER WAS INFORMED ABOUT THE RESULTS AND THEIR TRANSDUCER WAS REPLACED.

    Description of Event or Problem · 1

    (B)(6), BIOMED FOR PROVIDENCE HOSPITAL IN (B)(6), REPORTED TO FUJIFILM SONOSITE, INC. THAT A TECHNICIAN RECEIVED SHOCK DUE TO EXPOSED WIRES ON THE TRANSDUCER WHILE HE WAS SETTING UP FOR AN ULTRASOUND PROCEDURE. UPON FURTHER COMMUNICATION WITH THE TECHNICIAN, HE CLAIMED THAT HE FELT NUMBNESS IN HIS LEFT FIRST DIGIT. THE TECHNICIAN INFORMED FUJIFILM SONOSITE, INC. THAT HE REPORTED THE ISSUE TO EMPLOYEE HEALTH AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C60/5-2 MHZ TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC IYN FUJIFILM SONOSITE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1