BEUDAMED
    FDA Adverse Event Death Summary report: N

    PH AED G3

    MDR report key: 1673190 · Received April 29, 2010

    Report

    Report Number
    3014398-2010-00011
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 27, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN SENT IN FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ELECTRODE PADS WERE PLACED ON PT. AED KEPT SAYING "CHECK PADS" DURING THE RESCUE. EMS ARRIVED AND DETECTED 8 SHOCKABLE RHYTHMS ON THEIR AED. THE PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PH AED G3 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E-201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death