BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVID Q

    MDR report key: 6681024 · Received June 30, 2017

    Report

    Report Number
    9615849-2017-00001
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 13, 2017
    Manufacturer
    G.E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    ITX
    PMA / PMN Number
    K121062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED BECAUSE NO PATIENT WAS INVOLVED. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE CUSTOMER CONTACT INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND GE¿S INVESTIGATION IS COMPLETE. THE CUSTOMER REPORTED THAT TWO PHYSICIANS WERE INVOLVED IN TRANSPORTING THE ULTRASOUND UNIT WHEN THE INCIDENT OCCURRED. ONE WAS PULLING THE REAR HANDLE ON THE CART, AND THE OTHER WAS PUSHING FROM THE FRONT HAND REST ON THE CART. THEY WERE MOVING UP AN INCLINE WHEN THEY ENCOUNTERED AN UNEVEN SURFACE AND BOTH THE CART AND THE PERSON PUSHING TOPPLED OVER. THE PERSON PULLING WAS ABLE TO AVOID INJURY, AND THE PERSON PUSHING FELL ONTO THE CART AND SUSTAINED THE INJURIES. DEVICE EVALUATED BY MFR: UPDATED. GE¿S INVESTIGATION CONCLUDED THERE WAS NO MALFUNCTION INVOLVED, THE DESIGN PROVIDES SUFFICIENT STABILITY, THERE IS NO TREND OF INCIDENTS OF THIS TYPE, AND IT CONFIRMED THAT INSTRUCTIONS SAY TO PUSH THE CART FROM THE REAR HANDLE. THE CUSTOMER WAS GUIDED THROUGH INSTRUCTIONS FOR PUSHING THE CART FROM THE REAR HANDLE AS A CORRECTION.

    Description of Event or Problem · 1

    WHILE TRANSPORTING A VIVID-Q ULTRASOUND SYSTEM ATTACHED TO A SAFELOCK CART UP AN INCLINE A USER RECEIVED TWO LACERATIONS WHICH REQUIRED SUTURES, ONE ON EACH SHIN, DUE TO THE CART FALLING OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463781 VIVID Q VIVID Q W/SAFELOCK CART ITX G.E MEDICAL SYSTEMS ISRAEL LTD. 5412203/H45021CR 056234VQ/CP11451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other