BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE VIVID 7 ULTRASOUND

    MDR report key: 823519 · Received February 5, 2007

    Report

    Report Number
    9610482-2007-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2007
    Date of Event
    January 8, 2007
    Report Date
    February 5, 2007
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYO
    PMA / PMN Number
    k060542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE ULTRASOUND SYSTEM LOCKED-UP DURING SURGERY, RESULTING IN LOSS OF IMAGES AND USE OF A BACK-UP UNIT. NO INJURY WAS REPORTED. THE DELAY WITH EXTENDED TIME UNDER ANESTHESIA AND CARDIAC BYPASS MAY CONTRIBUTE TO INJURY, SHOULD A SIMILAR MALFUNCTION RECUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR