BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1313398 · Received February 18, 2009

    Report

    Report Number
    1720753-2008-27344
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    May 6, 2008
    Report Date
    May 15, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP WAS UNABLE TO DUPLICATE THE PROBLEM. THE ERROR LOG INDICATED THE GIB NODE WAS DROPPING OUT ON ARCNET INTERMITTENTLY. THIS PCB MAY BE CAUSING C-ARM LOCK UPS. THE SERVICE REP ORDERED PARTS FOR THE SYSTEM. HE REMOVED AND REPLACED THE GIB PCB. SYSTEM OPERATES AS INTENDED. TEST EQUIPMENT: FLUKE. THIS CORRECTION IS AS FOLLOWS: THIS MDR WAS ORIGINALLY SUBMITTED UNDER THE NUMBER 1720753-2008-021673. THAT NUMBER HAS ALSO BEEN SUBMITTED FOR MODEL 9800 SUBMITTED IN 2008. A NEW NUMBER HAS BEEN ASSIGNED TO THIS REPORT. WE ARE SUBMITTING THIS REPORT TO REPLACE THE DUPLICATE REPORT NUMBER FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DID NOT FLUORO, HAD NO IMAGES ON THE MONITOR, AND LOCKED-UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1