BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2042307 · Received February 15, 2011

    Report

    Report Number
    9680959-2011-00763
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 15, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 7700 SYSTEM WOULD NOT PRODUCE X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1