BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART AED G3

    MDR report key: 1651568 · Received April 2, 2010

    Report

    Report Number
    3014398-2010-00008
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    December 28, 2009
    Report Date
    April 2, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS SENT IN FOR EVAL AND DEPOT REPAIR WAS UNABLE TO DUPLICATE THE ERROR. THEY PERFORMED A 3 SHOCK SEQUENCE WITH NO PROBLEMS NOTED. THE MEMORY DUMP FILE FROM THE DEVICE WAS ALSO EVALUATED BY ENGINEERING. THE INITIAL CONCLUSION WAS THAT THE DEVICE DIDN'T DETECT PADS BEING PROPERLY PLACED IN THE RESCUE. THE FACT THAT NO ERROR HAD BEEN RECORDED IN THE SELF-TEST HISTORY OF THE DEVICE, INDICATED THAT THE DEVICE WORKED AS DESIGNED IN THIS RESCUE. FURTHER INVESTIGATION WAS PERFORMED ON (B) (6) 2010 AND CSC DETERMINED THERE WAS POTENTIAL FOR A HARDWARE FAILURE. A F/U REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT ON (B) (6) 2009, THE UNIT WAS USED IN A RESCUE, PADS WERE APPLIED BUT UNIT CONTINUED TO GIVE PROMPTS TO APPLY PADS. DEFIB UNIT REPEATEDLY ASKED TO ATTACH PADS WHICH HAD BEEN DONE AND VERIFIED. AFTER 3-5 PROMPTS, CREW IGNORED MACHINE VOICE PROMPTS AND CONTINUED WITH FOCUS ON CPR UNTIL ARRIVAL OF PARAMEDIC UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERHEART AED G3 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Death