BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUSON 730

    MDR report key: 833212 · Received October 25, 2006

    Report

    Report Number
    8020021-2006-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Date of Event
    August 29, 2006
    Report Date
    October 25, 2006
    Manufacturer
    GE KRETZTECHNIK GMBH & CO. OHG
    Product Code
    IYO
    PMA / PMN Number
    K933202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT SEVERAL DAYS AFTER A SERVICE CALL TO REPAIR A NON-IMAGING SYSTEM, ONE ULTRASOUND TRANSDUCER PRODUCED SHADOWING IN THE IMAGE AND ALL TRANSDUCERS HEATING MORE THAN NORMAL. NO INJURY WAS REPORTED, BUT BASED ON FURTHER INVESTIGATION, IT WAS BELIEVED A RECURRENCE OF THE MALFUNCTION COULD CAUSE SERIOUS INJURY. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUSON 730 DIAGNOSTIC ULTRASOUND IYO GE KRETZTECHNIK GMBH & CO. OHG KTZ156800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *