BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7G - 795200

    MDR report key: 6665168 · Received June 23, 2017

    Report

    Report Number
    3019216-2017-00020
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Report Date
    June 17, 2017
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K160807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION TO DETERMINE THE CAUSE OF THIS FAILURE IS CURRENTLY UNDERWAY. THE SYSTEM AND FAILED BATTERY ARE EXPECTED TO RETURN TO THE MANUFACTURING FACILITY FOR FURTHER ANALYSIS. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 1

    DUE TO THE HAZARDOUS CONDITION OF THE FAILED BATTERY AND THE SHIPPING RESTRICTIONS FOR DAMAGED/DEFECTIVE LITHIUM BATTERIES, THE DEVICE COULD NOT BE RETURNED TO NORTH AMERICA FOR A DETAILED FAILURE ANALYSIS FROM PHILIPS OR THE SUPPLIER. HOWEVER, VISUAL INSPECTION FROM PHOTOGRAPHS OF THE DAMAGED BATTERY BY PHILIPS ELECTRICAL ENGINEERING CONFIRMED THE ISSUE UNDERWENT THERMAL RUNAWAY. THERMAL RUNAWAY IS AN EXTREMELY RARE EVENT CAUSED BY SEVERAL POSSIBLE FLAWS WITHIN A CELL WHICH CAUSES A REACTION THAT SPREADS TO THE OTHER CELLS IN THE BATTERY. WHEN THIS UNAVOIDABLE ISSUE DOES OCCUR, THE BATTERY IS CONTAINED IN A METAL ENCLOSURE BEHIND A PLASTIC SHROUD THAT PROTECTS PATIENTS AND USERS FROM CONTACT WITH THE FAILED BATTERY.

    Description of Event or Problem · 1

    FOLLOWING A DEMONSTRATION PERFORMED AT A CUSTOMER SITE, SMOKE BEGAN TO EMANATE FROM THE BACK OF THE ULTRASOUND SYSTEM. A PHILIPS FIELD SERVICE ENGINEER WAS ON-SITE AND WITNESSED THE SMOKING SYSTEM. THE FSE NOTED THE BATTERY PACK WAS BURNING AT WHICH TIME HE PROMPTLY REMOVED THE BATTERY AND DISCONNECTED THE SYSTEM FROM POWER. THERE WAS NO REPORT OF ANY INJURY, SMOKE INHALATION OR IRRITATION CAUSED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445706 EPIQ 7G - 795200 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 IYN PHILIPS ULTRASOUND, INC EPIQ 7G - 795200 US216B0259

    Patients

    Seq Age Sex Outcome Treatment
    1