BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2913511 · Received December 21, 2012

    Report

    Report Number
    1720753-2012-10741
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM EXPERIENCED COMMUNICATION ERRORS. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP OR PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1