BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID I BT10*020473V

    MDR report key: 11243184 · Received January 28, 2021

    Report

    Report Number
    9615849-2021-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    December 29, 2020
    Report Date
    February 17, 2021
    Manufacturer
    G.E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    IYO
    PMA / PMN Number
    K092140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC'S INVESTIGATION HAS COMPLETED. THE POWER CABLE WAS DAMAGED AT THE STRAIN RELIEF, AND VISUAL INSPECTION DETERMINED THERE WAS A CRACK IN THE OUTER SHEATH & SHIELDING, AND NO BURN MARKS NOR HEAT DAMAGE, SUCH AS MELTING, TO THE CABLE WERE EVIDENT. IT IS CONCLUDED THAT THE MOST PROBABLE CAUSE OF CABLE DAMAGE WAS DUE TO WEAR AND TEAR OVER THE YEARS (SYSTEM WAS MANUFACTURED IN 2009). ADDITIONALLY, THE CUSTOMER CONTINUED TO USE THE CABLE KNOWING THERE WAS DAMAGE TO IT. GEHC EVALUATED COMPLAINT TRENDS AND DETERMINED THERE ARE NO TRENDS OF THIS ISSUE. RISK WAS EVALUATED AND IT HAS BEEN CONCLUDED THAT CURRENT MITIGATIONS ARE IN PLACE TO MAINTAIN THE RISK LEVEL AT AFAP. THE DAMAGED POWER CABLE WAS REPLACED, AND NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURED IN 2009. THEREFORE, NO UDI. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GEHC'S INVESTIGATION IS ONGOING AT THIS TIME. LEGAL MANUFACTURER: (B)(4).

    Description of Event or Problem · 1

    THE VIVID-I CART POWER CORD HAD SMOKE AND SMALL FIRE WHICH REQUIRED NO INTERVENTION TO RESOLVE. THE POWER CABLE WAS IMMEDIATELY REMOVED FROM THE MAINS SOCKET AND THE FLAME EXTINGUISHED BY ITSELF. THERE WAS NO PATIENT INVOLVED, AND NO INJURY OR OTHER DAMAGE REPORTED. GEHC VISUALLY INSPECTED THE POWER CORD AND FOUND A VISIBLE BREAK OF SHIELDING BETWEEN STRAIN RELIEF AND THE PLUG THAT CONNECTS TO THE CART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142693 VIVID I BT10*020473V ULTRASOUND SYSTEM, IMAGING, CARDIAC IYO G.E MEDICAL SYSTEMS ISRAEL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1