BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCESS CARDIO

    MDR report key: 497543 · Received November 18, 2003

    Report

    Report Number
    MW1030237
    Event Type
    Death
    Date Received
    November 18, 2003
    Date of Event
    October 30, 2003
    Report Date
    November 18, 2003
    Manufacturer
    ACCESS CARDIOSYSTEMS
    Product Code
    MVK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AED FAILURE. WHEN SHOCK WAS INDICATED UNIT FAILED TO DELIVER.

    Description of Event or Problem · 1

    THE ABOVE REFERENCED VOLUNTARY REPORT EVENT DOES NOT DESCRIBE ANY REPORTED EVENT TO ACCESS CARDIOSYSTEMS. THE DEVICE IDENTIFICATION IN THE REPORT DOES INDICATE THAT IT IS AN ACCESS CARDIOSYSTEMS DEVICE, BUT REFERENCES A PRODUCT CODE (MVK) THAT DOES NOT DESCRIBE THE AUTOMATED EXTERNAL DEFIBRILLATOR THAT ACCESS CARDIOSYSTEMS MARKETS (PRODUCT CODE MKJ). THE VOLUNTARY REPORT ALSO DESCRIBES AN EVENT IN A TIME PERIOD THAT THAT HAS NOT BEEN REPORTED TO THE COMPANY. THE MEDICAL DEVICE REPORTING OFFICE HOWEVER DID RECEIVE TWO OTHER VOLUNTARY REPORTS ON NOV. 2003 THAT DESCRIBED EVENTS CONCERNING THE ACCESS CARDIOSYSTEMS AUTOMATED EXTERNAL DEFIBRILLATOR. THE VOLUNTARY REPORT NUMBERS FOR THESE EVENTS ARE; MW1030300 AND MW1030301. SEPARATE LETTERS TO DISCUSS THESE EVENTS ARE BEING SUBMITTED CONCURRENTLY WITH THIS LETTER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 02/19/2004: THE ABOVE REFERENCED VOLUNTARY REPORT EVENT DOES NOT DESCRIBE ANY REPORTED EVENT TO ACCESS CARDIOSYSTEMS. THE DEVICE IDENTIFICATION IN THE REPORT DOES INDICATE THAT IT IS AN ACCESS CARDIOSYSTEMS DEVICE, BUT REFERENCES A PRODUCT CODE (MVK) THAT DOES NOT DESCRIBE THE AUTOMATED EXTERNAL DEFIBRILLATOR THAT ACCESS CARDIOSYSTEMS MARKETS (PRODUCT CODE MKJ). THE VOLUNTARY REPORT ALSO DESCRIBES AN EVENT IN A TIME PERIOD THAT HAS NOT BEEN REPORTED TO THE COMPANY. THE MEDICAL DEVICE REPORTING OFFICE HOWEVER DID RECEIVE TWO OTHER VOLUNTARY REPORTS ON NOVEMBER 18, 2003 THAT DESCRIBED EVENTS CONCERNING THE ACCESS CARDIOSYSTEMS AUTOMATED EXTERNAL DEFIBRILLATOR. THE VOLUNTARY REPORT NUMBERS FOR THESE EVENTS ARE; MW1030300 AND MW1030301. SEPARATE LETTERS TO DISCUSS THESE EVENTS ARE BEING SUBMITTED CONCURRENTLY WITH THIS LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS CARDIO AED MVK ACCESS CARDIOSYSTEMS * 9100-0100

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death