BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3801841 · Received February 11, 2014

    Report

    Report Number
    1720753-2014-01388
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PINS ON THE INTERCONNECT CABLE WERE FOUND LOOSE AND WERE RESEATED. THE GENERATOR SRAM BATTERY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR LOCK ERROR MESSAGE. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. 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
    90355 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1