BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIAC SCIENCE

    MDR report key: 566811 · Received January 7, 2005

    Report

    Report Number
    MW1034326
    Event Type
    Other
    Date Received
    January 7, 2005
    Report Date
    January 5, 2005
    Manufacturer
    CARDIAC SCIENCE, INC.
    Product Code
    MKJ
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN EMERGENCY RESCUE ATTEMPT USING CPR AND AND AED, THE AED WAS OBSERVED TO SHOCK THE PT WITH NO ONE PUSHING THE SHOCK/CONTINUE BUTTON. RESCUE DATA ALSO NOT RETRIEVABLE. AED SENT TO BIOMED. INVESTIGATION CONCLUDED THAT THE AED DID NOT CAUSE, OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC SCIENCE AED MKJ CARDIAC SCIENCE, INC. 9300 E-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other