BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIRST SAVE AED

    MDR report key: 1701331 · Received May 19, 2010

    Report

    Report Number
    3014398-2010-00013
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    April 10, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT BACK TO THE MFR (CSC) BUT HAS NOT BEEN EVALUATED YET. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT NOTHING HAPPENED WHEN THE ELECTRODE PADS WERE ATTACHED TO THE PT. THE POLICE OFFICER PERFORMING THE RESCUE STATED THEY ATTACHED THE AED AND PADS TO THE CHEST OF THE PT WHICH DID NOT READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST SAVE AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9200D-201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death