BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1735793 · Received June 17, 2010

    Report

    Report Number
    3004534508-2010-00005
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    September 1, 2009
    Report Date
    June 17, 2010
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT WAS DISCOVERED THROUGH A PUBLISHED ABSTRACT. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION, INCLUDING A DEATH CERTIFICATE OR AUTOPSY REPORT. AS OF 17-JUN-2010, THE PHYSICIAN/INSTITUTION HAS ONLY CONFIRMED THAT THE ADVERSE EVENT OCCURRED BETWEEN (B)(6)-(B)(6) 2009. A CSA MEDICAL SERVICE REPRESENTATIVE EVALUATED THE CONSOLE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED IN THE OPERATING ROOM. PHYSICIAN/INSTITUTION HAS NOT PROVIDED ADDITIONAL INFORMATION TO COMPANY AS OF 06/17/2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL, INC. CC2-NAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death