BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENOSCOP 6000 CCD

    MDR report key: 401096 · Received June 19, 2002

    Report

    Report Number
    9615767-2002-00017
    Event Type
    Death
    Date Received
    June 19, 2002
    Date of Event
    April 19, 2002
    Report Date
    June 19, 2002
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IZL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPIRED DUE TO MEDICAL CONDITIONS ONE DAY FOLLOWING WHICH WAS INTERRUPTED BY SHUT DOWN OF THE MOBILE FLUORO SYSTEM. THE MOBILE X-RAY SYSTEM STOPPED IMAGING DUE TO AN APPARENT OVER-TEMPERATURE CONDITION WITH THE X-RAY TUBE. AFTER DETAILED INVESTIGATION, IT WAS DETERMINED THAT THE TUBE UNIT HAD TOO MUCH OIL, CAUSING THE PRESSURE LIMIT SWITCH TO PREMATURELY DISABLE THE UNIT. BASED ON THIS NEW INFO, THE CO CONCLUDED THAT A MEDWATCH REPORT SHOULD BE SUBMITTED. THE SYSTEM WAS NOT UNDER SERVICE CONTRACT BY GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOP 6000 CCD DIAGNOSTIC X-RAY IZL GE MEDICAL SYSTEMS EUROPE 2123012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death