BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3033052 · Received April 1, 2013

    Report

    Report Number
    9680959-2013-00684
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GENERATOR ERROR SEVERAL TIME. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132115 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1