BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1915620 · Received April 25, 2008

    Report

    Report Number
    1720753-2008-21040
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM WILL NOT BOOT UP, THE SYSTEM HUNG DURING A BOOT PROCESS BEFORE CYSTO PROCEDURE, AND DURING A SECOND ATTEMPT, THE SYSTEM BOOTED AND CASES WERE CONDUCTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1