BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2960617 · Received January 25, 2013

    Report

    Report Number
    1720753-2013-01107
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 25, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND PROBLEMS WITH THE HARD DRIVE AND ONE OF THE POWER SUPPLIES, 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 PRODUCE AN IMAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35328 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1