BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2023492 · Received March 1, 2011

    Report

    Report Number
    1720753-2011-01739
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP PERFORMED AN ON SITE INVESTIGATION. DIAGNOSTIC TESTING WAS PERFORMED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM SHUTS DOWN INTERMITTENTLY. THE SYSTEM ALSO INTERMITTENTLY DOES NOT BOOT UP. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1