BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID I

    MDR report key: 9671392 · Received February 5, 2020

    Report

    Report Number
    9615849-2020-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 11, 2020
    Report Date
    April 16, 2020
    Manufacturer
    G.E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    ITX
    PMA / PMN Number
    K121062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC'S INVESTIGATION HAS COMPLETED. THE VIVID-I BATTERY WAS RETURNED TO GEHC FOR IN-DEPTH ANALYSIS, AND THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE IS RELATED TO FAILURE IN THE LITHIUM ION CELL WHICH CAUSED THE BATTERY TO FAIL AND LED TO THERMAL RUNAWAY. THIS EVENT OCCURS ONCE OUT OF ~1.5 MILLION CELLS OF THIS MODEL THAT HAVE BEEN IMPLEMENTED IN ALL GE PRODUCTS. ADDITIONALLY, THERE IS NO PROCESS ROOT CAUSE. THE DAMAGED DEVICE WAS TAKEN OUT OF SERVICE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. UDI: NOT APPLICABLE. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. LEGAL MANUFACTURER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A FIRE STARTED FROM A BATTERY-POWERED ULTRASOUND DEVICE, THE VIVID I. THEY REPORTED IGNITION, SPARKS AND SMOKE FROM THE REAR/BACK OF THE VIVID I. THE FIRE WAS EXTINGUISHED BY A FIRE EXTINGUISHER (C02 INITIALLY AND THEN SPRAYED WATER BECAUSE IT COULD NOT BE EXTINGUISHED). AT THE TIME OF THE EVENT THE VIVID I WAS ON A CART AND WAS BATTERY POWERED (NO AC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138041 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM ITX G.E MEDICAL SYSTEMS ISRAEL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1