BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 2241268 · Received August 17, 2011

    Report

    Report Number
    9680959-2011-09827
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    April 22, 2010
    Report Date
    August 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED AN OVER THE PHONE EVAL. THE FOOT PEDAL APPEARS TO HAVE BEEN DEPRESSED DURING BOOT UP. THE CUSTOMER REPORTS THAT THE SYSTEM OPERATES AS INTENDED. 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 APRIL 26, 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 THE TEMPERATURE GAUGE WAS FLASHING. 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