BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3000966 · Received February 27, 2013

    Report

    Report Number
    1720753-2013-03206
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 27, 2013
    Manufacturer
    GE OEC MEDICAL
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMAGES WERE NOT BEING SAVED AND PT DATA AND IMAGES WERE MIXED UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83791 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL 2800

    Patients

    Seq Age Sex Outcome Treatment
    1