BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2000

    MDR report key: 1232517 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28059
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP FOUND THAT THERE WAS A HARD DRIVE DATA BLOCK ERROR AND LIMITED ABILITY TO RECALL IMAGES. THIS SYSTEM IS END OF LIFE. A REPLACEMENT HARD DRIVE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A DATA BLOCK ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1