BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7G - 795200

    MDR report key: 5064804 · Received September 9, 2015

    Report

    Report Number
    3019216-2015-00048
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    September 3, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICAL ASSESSMENT FOLLOWING LIVE SCANNING TESTING CONCLUDED THERE WAS NO SAFETY RISK. BASED ON THE IMAGES PROVIDED BY THE CUSTOMER, VARIOUS CHANGES IN THE PARAMETERS WERE IDENTIFIED THAT COULD DECREASE IMAGE QUALITY AND COLOR FLOW. THE IMAGES REVEALED THAT THE USERS CHANGED THE FREQUENCY OPTIMIZATION SETTINGS TO LOW FROM ITS DEFAULT OF MEDIUM WHICH WILL LEAD TO LESS COLOR SENSITIVITY AT THE TYPICAL CLINICAL IMAGING DEPTHS. ADDITIONALLY, LACK OF STANDARD COLOR CONTROL ADJUSTMENTS; SUCH AS, DECREASING COLOR VELOCITY SCALE AND INCREASING COLOR GAIN, WERE NOT PERFORMED. RECOMMENDATIONS WERE PROVIDED TO THE CUSTOMER AS BEST PRACTICES FOR INCREASED COLOR/CPA SENSITIVITY. THE INVESTIGATION CONCLUDED, NO MALFUNCTION OF THE EPIQ SYSTEM OCCURRED AND OPTIMAL DIAGNOSTIC COLOR PERFORMANCE CAN BE ACHIEVED WITH NORMAL MANIPULATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    SONOGRAPHER REPORTED THEIR EPIQ 7G ULTRASOUND SYSTEM DID NOT PROVIDE ACCURATE DIAGNOSTIC EXAM RESULTS USING COLOR DOPPLER - THEY STATED LOW COLOR FLOW WAS NOT DETECTED. PATIENT WAS MOVED TO ANOTHER ULTRASOUND SYSTEM AND THEY WERE ABLE TO CONFIRM THE DIAGNOSIS. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595531 EPIQ 7G - 795200 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 IYN PHILIPS ULTRASOUND, INC EPIQ 7G - 795200 US215B0435

    Patients

    Seq Age Sex Outcome Treatment
    1