BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3894302 · Received April 23, 2014

    Report

    Report Number
    9680959-2014-00573
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 23, 2014
    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

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM SHUT DOWN DURING A PROCEDURE. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. 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
    245276 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1