BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3182521 · Received June 14, 2013

    Report

    Report Number
    1720753-2013-07121
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE AND AN ALTERNATE SYSTEM WAS REQUIRED TO COMPLETE THE CASE. THIS ERROR MESSAGE WAS LIKELY CAUSING THE SYSTEM TO SHUT DOWN OR LOCK-UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272246 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1