BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1973672 · Received January 18, 2011

    Report

    Report Number
    1720753-2011-00370
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 26, 2010
    Report Date
    January 18, 2011
    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

    THE SYSTEM WAS NOT EVALUATED BY A GE REPRESENTATIVE. THE CUSTOMER CLEARED THE FAULT AND CANCELLED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR MESSAGE AND WOULD NOT BOOT UP DURING A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1