BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2896853 · Received December 28, 2012

    Report

    Report Number
    1720753-2012-10877
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 28, 2012
    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

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED FATAL ERROR. THE FIELD ENGINEER NOTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    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