BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIQ 7C - 795201

    MDR report key: 7085027 · Received December 5, 2017

    Report

    Report Number
    3019216-2017-00044
    Event Type
    Death
    Date Received
    December 5, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 28, 2017
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K160807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION TO DETERMINE THE CAUSE OF THIS ISSUE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED TO PROVIDE ADDITIONAL EVALUATION DETAILS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE SYSTEM LOCKUP WAS DETERMINED TO HAVE BEEN CAUSED BY THE FAILURE OF THE X5-1 TRANSDUCER. A THOROUGH EVALUATION OF THE FAILED TRANSDUCER WAS PERFORMED. A FUNCTIONAL TEST CONFIRMED THE TRANSDUCER FAILURE AND A CT SCAN VERIFIED A BREAK IN THE TRANSDUCER¿S COAX WIRING. UPON FURTHER DESTRUCTIVE TESTING, THREE BROKEN WIRES WERE IDENTIFIED NEAR THE SENSOR INTERFACE AND DEGRADATION OF THE INSULATION OF COAX WIRES WAS ALSO EVIDENT, WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE OF THE WIRES. FURTHER ANALYSIS NOTED THE WIRES WERE FRAYED AND TORN AND APPEARED PINCHED WHICH IS INDICATIVE OF ABNORMAL WEAR. THE INVESTIGATION CONCLUSION DETERMINED TWISTING AND DISTORTION MAY HAVE INDUCED STRESS ON THE WIRES WHICH LED TO THE BREAKDOWN. QUALITY IMPROVEMENT ACTIVITIES FOR THE X5-1 TRANSDUCER CABLE ARE ONGOING IN PARALLEL WITH THE FOLLOWING EFFORTS: (B)(4): X5-1 TRANSDUCER SENSOR INTERFACE CABLE AND MID-SPAN-TENSION CABLE DESIGN ENHANCEMENTS. (B)(4): X5-1 TRANSDUCER CAPACITOR DESIGN ENHANCEMENTS. FLUOROSCOPY WAS USED AS THE PRIMARY IMAGING DEVICE FOR STENT PLACEMENT DURING THIS INCIDENT AND WAS NOT AFFECTED BY THE X5-1 ISSUE. SINCE THE ULTRASOUND SYSTEM WAS INTENDED TO BE USED AS A SECONDARY DEVICE, WE COULD NOT CONCLUDE THAT THE EPIQ SYSTEM CONTRIBUTED TO THE PATIENT¿S OUTCOME. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT HAD EXPIRED WHILE ATTEMPTING TO USE AN EPIQ ULTRASOUND SYSTEM FOR A STENT DEPLOYMENT PROCEDURE. THE ULTRASOUND UNIT LOCKED UP PRIOR TO STARTING THE EXAMINATION. AS THE CUSTOMER RETRIEVED AND PREPARED A PHILIPS IE33 ULTRASOUND SYSTEM FOR USE IN PLACE OF THE EPIQ, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861958 EPIQ 7C - 795201 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 IYN PHILIPS ULTRASOUND, INC EPIQ 7C - 795201 B1X5MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death