BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3190017 · Received June 18, 2013

    Report

    Report Number
    1720753-2013-07353
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FOLLOWING COMPONENTS WERE RESEATED: THE STATOR CONNECTIONS, POWER RELAY BOARD AND GENERATOR INTERFACE BOARD. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS SHUTTING DOWN WITHOUT COMMAND DURING A CASE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277142 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1