BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 754295 · Received October 20, 2005

    Report

    Report Number
    2132572-2005-00005
    Event Type
    Other
    Date Received
    October 20, 2005
    Date of Event
    September 14, 2005
    Report Date
    October 17, 2005
    Manufacturer
    CARDIAC SCIENCE, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AED WAS FOUND TO PERFORM A RESCUE WITHIN SPECIFICATION. THIS IS A NONSHOCKABLE RHYTHM AND SHOULD NOT HAVE BEEN FOUND AS A SHOCKABLE RHYTHM. THE RELATIVELY LONG PERIOD AT THE BEGINNING OF THE ANALYSIS (3.7 SECONDS) WITHOUT A COMPLEX, CAUSED THE ANALYSIS ALGORITHM TO LOOK FOR INCREASING SMALL "PEAKS." THE HIGH FREQUENCY BASELINE NOISE WAS ABOVE THE MINIMUM THRESHOLD AMPLITUDE AND INTERPRETED AS SHOCKABLE. THIS EVENT HAS BEEN FORWARDED TO THE ENGINEERING STAFF TO BE USED TO IMPROVE THE ANALYSIS ALGORITHM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY POLICE DEPARTMENT PERSONNEL THAT DURING AN ATTEMPTED RESCUE OF A SUSPECTED CARDIAC ARREST VICTIM, THE DEVICE DELIVERED THE APPROPRIATE SHOCK AND CONVERTED THE PATIENT'S ARRHYTHMIA. SUBSEQUENTLY, THE DEVICE RECOMMENDED AND DELIVERED A SECOND SHOCK WHEN THE RHYTHM WAS NON-SCHOCKABLE. THE PATIENT SURVIVED AFTER THE SECOND SHOCK. THE PATIENT'S RATE THEN CHANGED AND THE DEVICE DID NOT RECOMMEND AN ADDITIONAL SHOCK. THE AED AND THE BATTERY WERE SUBSEQUENTLY RETURNED TO THE MANUFACTURER FOR EVALUATION AND FOUND TO PERFORM WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * POWERHEART G3 AED MKJ CARDIAC SCIENCE, INC. 9300E-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other