BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP/12-5 MHZ TRANSDUCER

    MDR report key: 824876 · Received February 23, 2007

    Report

    Report Number
    3032367-2007-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 2, 2007
    Manufacturer
    SONOSITE,INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED ANY CUSTOMER REPORTS REGARDING THIS ISSUE AND THERE HAVE BEEN NO INJURIES OR ILLNESSES REPORTED AS A RESULT OF THIS SITUATION.

    Description of Event or Problem · 1

    DURING EMC TESTING, WE DISCOVERED THAT THE LAP TRANSDUCER EXCEEDS THE LIMITS SPECIFIED FOR RADIO-FREQUENCY EMISSIONS BY UP TO 10 DB. CISPR 11 SECTION 5.2.2 TABLE 3 SPECIFIES THE LIMIT AT 40 DB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP/12-5 MHZ TRANSDUCER LAPAROSCOPIC ULTRASOUND TRANSDUCER ITX SONOSITE,INC. P05507-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other