BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3791962 · Received January 3, 2014

    Report

    Report Number
    9680959-2014-00009
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE B388 AND B386 PCB ASSEMBLIES WERE IDENTIFIED AS RECOMMENDED FOR REPLACEMENT. AT THIS TIME THE CUSTOMER HAS REFUSED ADDITIONAL SERVICE. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4092 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1