BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3042473 · Received April 3, 2013

    Report

    Report Number
    1720753-2013-04600
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE GENERATOR INTERFACE BOARD'S COIN BATTERY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTERMITTENTLY, THE FIRST EXPOSURE WILL LOCK UP THE SYSTEM. (INTERMITTENT SYSTEM LOCK UP). THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136906 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1