BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1973714 · Received January 18, 2011

    Report

    Report Number
    1720753-2011-00328
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. A LOOSE CONNECTION ON THE CAMERA WAS REPAIRED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO PRODUCE FLUOROSCOPY XRAY. NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1