BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 3101557 · Received May 1, 2013

    Report

    Report Number
    1720753-2013-05563
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC0
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE AND FLOPPY DRIVE, AND SENT THE MOTHERBOARD FOR REPAIR, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190723 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC0 2600

    Patients

    Seq Age Sex Outcome Treatment
    1