BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSITE L38 TRANSDUCER

    MDR report key: 958728 · Received December 5, 2007

    Report

    Report Number
    3032367-2007-00002
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    November 5, 2007
    Report Date
    December 4, 2007
    Manufacturer
    SONOSITE,INC.
    Product Code
    ITX
    PMA / PMN Number
    K052109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED 180 HAND HELD ULTRASOUND SYSTEM THAT WAS USED IN CONJUNCTION WITH THE TRANSDUCER WAS TESTED FOR ELECTRICAL SAFETY PER THE TEST PROCEDURE. THE SYSTEM PASSED ALL ELECTRICAL SAFETY REQUIREMENTS. THE SYSTEM WAS THEN TESTED TO THE FUNCTIONAL ACCEPTANCE TEST. TESTING OCCURRED IN 2007. THE ENVIRONMENTAL CONDITIONS AT THE TIME OF THE SHOCK WERE COLD AND DRY. BASED ON THE RESULTS OF THE TESTING PERFORMED AND THE ENVIRONMENTAL CONDITIONS AT THE TIME OF THE INCIDENT, IT IS OUR DETERMINATION THE MOST LIKELY CAUSE OF THE SHOCK WAS ELECTRO STATIC DISCHARGE.

    Description of Event or Problem · 1

    THE TECHNICIAN WAS PREPARING TO PERFORM AN ULTRASOUND PROCEDURE ON A PATIENT. THE TECHNICIAN REPORTED RECEIVING A SHOCK FROM THE TRANSDUCER. THE TECHNICIAN VISITED THE DOCTOR AS A RESULT OF THE SHOCK WITH NO ISSUE IDENTIFIED. THERE WAS NO MARK OR BURN RESULTING FROM THE SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOSITE L38 TRANSDUCER TRANSDUCER, L38 10-5 MHZ, LINEAR ITX SONOSITE,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization SITESTAND PART NUMBER P01606-02| PRODUCT #:P02464-05| ULTRASOUND GEL| 180 HAND HELD ULTRSOUND SYSTEM| VENUS ULTRASOUND BAG