BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 2241260 · Received August 17, 2011

    Report

    Report Number
    9680959-2011-09784
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    January 15, 2010
    Report Date
    August 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE, AND NO ADD'L SERVICE INFO WAS PROVIDED. DURING A RETROSPECTIVE REVIEW, THIS EVENT WAS DETERMINED TO BE REPORTABLE. IT WAS INCLUDED AS PART OF A RETROSPECTIVE SUMMARY REPORT (RSR) REQUEST TO FDA ON (B)(4) 2011 (B)(4). FDA REQUESTED THIS EVENT TO BE REMOVED FROM THE RSR REQUEST AND FILED VIA 3500A.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS HIGH VOLTAGE ARCING IN THE TUBE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1