BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE INNOVA 2000

    MDR report key: 5492310 · Received April 13, 2005

    Report

    Report Number
    5492310
    Event Type
    Malfunction
    Date Received
    April 13, 2005
    Date of Event
    February 12, 2005
    Report Date
    March 30, 2005
    Manufacturer
    GE HEALTHCARE
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO CARDIAC CATH LAB AFTER HAVING TWO SEPARATE OCCURENCES OF CARDIAC ARREST. THE DIAGNOSTIC PORTION OF THE PROCEDURE WAS COMPLETED WHEN PATIENT HAD CARDIAC ARREST FOR THE THIRD TIME. CPR WAS INITIATED. THE FLUOROSCOPY FAILED WHEN PHYSICIAN ATTEMPTED TO CONTINUE WITH THE FINAL ATTEMPT AT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE INNOVA 2000 CATHETERIZATION LABORATORY JAA GE HEALTHCARE 2149521-3

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR