BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3093451 · Received April 26, 2013

    Report

    Report Number
    9680959-2013-00854
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, "SYSTEM NOT INITIALIZING." THIS ISSUE MAY REFER TO THE SYSTEM NOT BEING ABLE TO BOOT UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181734 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1