BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONARA

    MDR report key: 2607654 · Received April 19, 2011

    Report

    Report Number
    3008289288-2011-00001
    Event Type
    Other
    Date Received
    April 19, 2011
    Date of Event
    September 8, 2010
    Report Date
    March 5, 2011
    Manufacturer
    CAREFUSION 209 INC.
    Product Code
    IYN
    PMA / PMN Number
    K060421
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN A FACILITY STAFF MEMBER WAS PRACTICING WITH THE EQUIPMENT, SHE TOUCHED THE DEVICE TO HER NECK AND EXPERIENCED AN ELECTRICAL SHOCK. REF REPORT (B)(4). CAREFUSION DID NOT REPORT THIS EVENT BECAUSE THERE WAS NO DEATH OR SERIOUS INJURY OR THAT THE EQUIPMENT MALFUNCTIONED AND WOULD CAUSE DEATH OR SERIOUS INJURY. PRODUCT WAS RETURNED TO CAREFUSION (CF) ON (B)(6) 2010. CF ENGINEER INSPECTED 2 MHZ PROBE AND SONARA UNILATERAL CHASSIS. PROBE: THERE WERE NO CRACKS TO THE PROBE BODY AND NO DAMAGE TO THE CABLE OR CONNECTOR. THE PROBE WAS HI-POT AND LEAKAGE TESTED AND NO DIELECTRIC BREAKDOWN OCCURRED. CHASSIS: SYSTEM WAS TESTED FOR HI-POT, GROUND BOND AND LEAKAGE. NO ISSUES WERE IDENTIFIED. THE CHASSIS WAS OPENED AND THE AC WIRING FROM THE AC ENTRANCE TO THE LOW VOLTAGE POWER SUPPLY AC INLET WERE INSPECTED. NO DETERIORATION ON THE MAINS INSULATION WAS NOTED. THE CHASSIS WAS REASSEMBLED AND TESTED AGAIN FOR HI-POT, GROUND BOND AND LEAKAGE. NO DIELECTRIC BREAKDOWN OCCURRED. GROUND BOND TEST SHOWED THAT THE GROUND CONTINUITY WAS WITHIN NORMAL LIMITS. RETESTED THE FUNCTION OF THE TRANS CRANIAL DOPPLER SYSTEM AFTER INSPECTION AND SUBSEQUENT SAFETY TESTING. NORMAL BLOOD FLOWS WERE OBTAINED AND NO SHOCK SENSATION WAS NOTED. THE STANDARD PRODUCTION SAFETY TESTING WAS PERFORMED ON THE SYSTEM AND NO ISSUES WERE IDENTIFIED. ISSUE COULD NOT BE DUPLICATED. ADVISED THE USER TO VERIFY TO ENSURE THAT THE AC MAINS ARE WIRED CORRECTLY. ADVISED THE USER TO VERIFY THAT THE SYSTEM POWER CORD IS CONFIGURED CORRECTLY. REPLACED THE 2 MHZ PROBE AS A PRECAUTIONARY ACTION. ADVISE THE USER THAT ALL USB DEVICES WITH EXTERNAL SUPPLIES MUST BE POWERED THROUGH THE ISOLATION TRANSFORMER. DISCUSSED THIS WITH THE CUSTOMER, VIA PHONE. NO ISSUES WERE IDENTIFIED WITH THE CURRENT CONFIGURATION OF THE SYSTEM, BUT THE CONFIGURATION AT THE TIME OF THE INCIDENT IS UNK. A RECOMMENDATION THAT THE FACILITY WIRING BE TESTED WAS ALSO MADE AT THAT TIME. CF CONSIDERS THIS ISSUE CLOSED, THIS IS THE FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONARA ULTRASOUND, DOPPLER, TRANS CRANIAL IYN CAREFUSION 209 INC. UNILATERAL SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other