BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID 7

    MDR report key: 2062270 · Received March 17, 2011

    Report

    Report Number
    9610482-2011-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYO
    PMA / PMN Number
    K060542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIOVASCULAR SCAN OF A NEONATAL CHILD, THE ECHO TECHNICIAN WAS UNABLE TO ACCURATELY VIEW THE PT'S HEART AND WAS UNABLE TO VIEW A DEFECT THAT WAS LATER REVEALED WITH ANOTHER DEVICE. THIS EVENT WAS DESCRIBED BY THE SITE AS A LIFE THREATENING ISSUE WHICH COULD HAVE RESULTED IN MISDIAGNOSIS. GE HEALTHCARE WAS UNABLE TO CONFIRM THIS STATEMENT AT THIS TIME. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID 7 ULTRASONIC IMAGING SYSTEM IYO GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1