BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3874708 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03590
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BATTERY PACK 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 CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A PRECHARGE VOLTAGE ERROR AND FILAMENT REGULATOR ERROR. THE SYSTEM WAS NOT ABLE TO PROVIDE ENOUGH POWER TO CREATE EXCESSIVE RADIATION. THE PRECHARGE VOLTAGE ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248285 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1