BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2191238 · Received July 19, 2011

    Report

    Report Number
    1720753-2011-20175
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS REMOVED AND THE COMPACT FLASH UPGRADE KIT WAS INSTALLED. THE SOFTWARE WAS RE-INSTALLED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1