BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2891451 · Received December 6, 2012

    Report

    Report Number
    1720753-2012-10195
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 25, 2012
    Report Date
    December 6, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CABLES NEEDED TO BE REPLACED. THE CUSTOMER CHOSE NOT TO REPAIR THE SYSTEM AND CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE, THE FSE NOTED THE SYSTEM WAS UNABLE TO MAKE FLUOROSCOPIC EXPOSURES AND DISPLAYED THE ERROR MESSAGE AT BOOT UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1