BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3042526 · Received April 3, 2013

    Report

    Report Number
    1720753-2013-04570
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY CONNECTORS WERE CLEANED, THE POWER SUPPLY VOLTAGE WAS ADJUSTED, AND THE POWER PLUG WAS TIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EXPOSURE FLUORO BUTTON FROZE DURING PROCEDURE AND STARTED BEEPING, AND THE SYSTEM REQUIRED A REBOOT. THE CUSTOMER'S DESCRIPTION IS INDICATIVE OF A SYSTEM LOCK UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137414 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1