BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2043010 · Received March 25, 2011

    Report

    Report Number
    9617766-2011-00702
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 25, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT FIND THE PROBLEM AFTER EXTENSIVE TROUBLESHOOTING. MANUFACTURER'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HEARD A LOUD BANG, FOLLOWED BY SMOKE COMING OUT OF THE SYSTEM, AND THE SYSTEM STOPPED WORKING. NO PATIENT OR STAFF INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1