BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVID Q MOBILE CART

    MDR report key: 1522955 · Received November 5, 2009

    Report

    Report Number
    9615849-2009-00001
    Event Type
    Injury
    Date Received
    November 5, 2009
    Date of Event
    October 8, 2009
    Report Date
    November 5, 2009
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
    Product Code
    IYN
    PMA / PMN Number
    K082374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM ANALYSIS OF PHOTOS OF THE BROKEN CONNECTOR, THE CABLE MANUFACTURER CONCLUDES THAT A FORCEFUL ABRUPT PULL FROM THE TOP TO THE BOTTOM OF THE CONNECTOR CAUSED THE DAMAGE. THE CONNECTOR IS CERTIFIED AS MEETING THE REQUIREMENTS OF SAFETY STANDARD. DESTRUCTIVE TESTING OF SAMPLES OF THE SAME CONNECTOR SHOWED AN AVERAGE FORCE OF 112 POUNDS APPLIED AT RIGHT ANGLE IS REQUIRED TO PRODUCE A SIMILAR FAILURE. IT IS CONCLUDED THAT EXCESSIVE ABUSE (FORCE, PRESSURE OR IMPACT) IS NEEDED TO CAUSE A FAILURE OF THE TYPE THAT EXPOSE THE INTERNAL CONDUCTORS OF THE MAINS CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT A NURSE RECEIVED AN ELECTRICAL BURN WHILE GRASPING THE APPLIANCE INLET CONNECTOR OF A MAINS CORD WHICH SUPPLIES POWER TO THE MOBILE CART ACCESSORY FOR THE VIVID Q ULTRASOUND SYSTEM. THE CORD, WHICH HAD A SEVERELY DAMAGED CONNECTOR WITH EXPOSED CONDUCTORS, WAS PLUGGED INTO THE WALL OUTLET BUT NOT CONNECTED TO THE CART. UPON CONTACTING THE LIVE CONDUCTORS, THE NURSE WAS SHOCKED CAUSING SIGNIFICANT BURNS TO HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID Q MOBILE CART ULTRASONIC PULSED DOPPLER IMAGING SYST IYN GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization