BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAXX ULTRASOUND SYSTEM

    MDR report key: 1804742 · Received August 11, 2010

    Report

    Report Number
    3032367-2010-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    March 3, 2007
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYN
    PMA / PMN Number
    K053069
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SPEAKING WITH THE CUSTOMER, THE DEATH OF THE FETUS OCCURRED PRIOR TO THE USE OF THE MICROMAXX ULTRASOUND SYSTEM. (B)(4), "THERE IS NO EVIDENCE LINKING THE DEATH OF THE TWIN TO THE EQUIPMENT FAILURE." ALTHOUGH SONOSITE DOES NOT BELIEVE THIS INCIDENT MEETS THE DEFINITION OF AN MDR REPORTABLE EVENT, WE HAVE INCLUDED A COPY OF OUR EVALUATION OF THE SYSTEM AND TRANSDUCER INVOLVED IN ORDER TO PROVIDE INFORMATION ON SONOSITE'S INVESTIGATION OF THE TRANSDUCER AND SYSTEM. THE CUSTOMER RETURNED THEIR MICROMAXX ULTRASOUND SYSTEM (B)(4) AND C60E/5-2 MHZ TRANSDUCER (B)(4) FOR EVALUATION. IMPEDANCE TESTING WAS PERFORMED ON THE C60E TRANSDUCER. AS A RESULT OF THIS TESTING, SONOSITE WAS ABLE TO IDENTIFY AN ELECTRICAL SHORT IN THE TRANSDUCER CABLE. WE CONFIRMED THAT ON 06/19/2007, THE TRANSDUCER UNDERWENT AN IMPEDANCE TEST AS IS REQUIRED BY OUR STANDARD MANUFACTURING PROCESS PRIOR TO SHIPMENT TO A CUSTOMER. THE RESULTS OF THE TEST AT THAT TIME WERE SUCCESSFUL, THEREFORE, WE BELIEVE THE SHORT OCCURRED AFTER THE TRANSDUCER LEFT THE FACTORY, MOST LIKELY THE RESULT OF MISHANDLING OF THE TRANSDUCER. AN EVALUATION OF THE MICROMAXX SYSTEM IDENTIFIED A SHORT ON THE HV PULSER LINE ON THE SYSTEM'S MAIN CIRCUIT BOARD. OUR ENGINEERING ANALYSIS HAS DETERMINED THAT THE SHORT ON THE SYSTEM'S MAIN BOARD WAS CAUSED BY THE SHORT FOUND IN THE CUSTOMER'S C60E TRANSDUCER. IN SEPTEMBER, 2008, SONOSITE IMPLEMENTED A MORE ROBUST CABLE DESIGN ON THE C60E TRANSDUCER TO IMPROVE THE RELIABILITY OF THE TRANSDUCER CABLE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMAXX ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND SYSTEM IYN SONOSITE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1