BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3101956 · Received May 3, 2013

    Report

    Report Number
    1720753-2013-05689
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE FILMER NEEDED TO BE REPAIRED, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE. THE CUSTOMER DECLINED REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT PRODUCT X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195199 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1