BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2030961 · Received March 4, 2011

    Report

    Report Number
    1720753-2011-01924
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REP REPLACED THE FUSE. THE SYSTEM IS NOW OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PRECHARGE FAILURE ERROR MESSAGE ON THE CONTROL PANEL DISPLAY OF THE 2600 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1