BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID S6

    MDR report key: 10583284 · Received September 24, 2020

    Report

    Report Number
    9615849-2020-00002
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    July 25, 2020
    Report Date
    November 24, 2020
    Manufacturer
    G.E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    IYN
    PMA / PMN Number
    K121063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC'S INVESTIGATION HAS COMPLETED. THE VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM WAS REPLACED TO CORRECT THE ISSUE. THE FAILED COMPONENT, THE LITHIUM BATTERY, WAS EVALUATED TO DETERMINE ROOT CAUSE OF THE SMOKE AND/OR SMOLDERING. IT IS CONCLUDED THE MOST PROBABLE ROOT CAUSE IS A FAILURE WITHIN A LITHIUM ION CELL WHICH CAUSED THE BATTERY TO FAIL AND LED TO THERMAL RUNAWAY. THERE WERE NO OPEN FLAMES OR FIRE OR RISK OF TOXIC EFFECTS DUE TO THE CONSTRUCTION AND MATERIALS THAT CONFORM TO SAFETY STANDARDS. THE RISK FILE WAS EVALUATED AND IT IS CONCLUDED THAT MITIGATIONS ARE APPROPRIATE AND SUFFICIENT. ADDITIONALLY, THE COMPLAINT FILE WAS REVIEWED AND IT IS CONCLUDED THERE ARE NO TRENDS OF LITHIUM ION CELL FAILURES. THEREFORE, GEHC HAS CONCLUDED NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UDI: DEVICE WAS MANUFACTURED IN 2012 AND THERE IS NO UDI. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: (B)(4). GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A LITTLE BIT OF SMOKE COMING OUT OF THE VIVID S6 ULTRASOUND SYSTEM. THERE WAS NO OPEN FIRE, AND A FOAM EXTINGUISHER WAS USED TO EXTINGUISH THE SMOKE. THE CUSTOMER REPORTED NO IMPACT TO PATIENTS OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049142 VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM IYN G.E MEDICAL SYSTEMS ISRAEL LTD. N/A 7411VS6

    Patients

    Seq Age Sex Outcome Treatment
    1