BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3161700 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06718
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESETATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERLOCK CIRCUITRY CONNECTIONS WERE CLEANED AND RESEATED, AND THE PS2 POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN INTERLOCK FAILURE ERROR MESSAGE WHICH WAS NOT ABLE TO BE CLEARED BY REBOOTING THE SYSTEM. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242692 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1