BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2062011 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03269
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE EMERGENCY STOP SWITCH WAS REPAIRED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS NO IMAGE DISPLAYED AND THE 2800 SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1