BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3963022 · Received June 11, 2014

    Report

    Report Number
    1720753-2014-04909
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE EVALUATED THE SYSTEM, BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT PERFORM FLUOROSCOPY. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345088 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1