BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE

    MDR report key: 4911463 · Received July 10, 2015

    Report

    Report Number
    3003521780-2015-00010
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    May 18, 2015
    Report Date
    December 1, 2015
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    PMA / PMN Number
    K033896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, TO DATE, THE ELECTRONIC HISTORY FILES FROM THE AED HAVE NOT BEEN RETURNED FROM THE CUSTOMER. ADDITIONALLY, THE CUSTOMER HAS NOT PROVIDED THE SERIAL NUMBER FROM THE AED ASSOCIATED WITH THIS EVENT AND LITTLE INFORMATION IS KNOWN. THE INVESTIGATION REMAINS OPEN AND NO CONCLUSIONS CAN BE MADE AT THIS TIME. BASED ON THE OUTCOME OF THE INVESTIGATION, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 AFTER CONTACTING THE INITIAL REPORTER AND REQUESTING MORE INFORMATION ABOUT THE REPORTED EVENT, WE WERE FORWARDED TO BRIDGETT LOSEE, (208-776-5221 X 102) THE PERSON WHO WAS INVOLVED WITH THIS RESCUE ATTEMPT. BRIDGETT STATED THAT THE EVENT OCCURRED ON (B)(6) 2015 NOT IN APRIL AS INITIALLY REPORTED. EXAMINATION OF THE ELECTRONIC EVENT RECORD FROM THE AED FOR (B)(6) 2015 REVEALS A PATIENT WHO IS ASYSTOLIC; ASYSTOLE BEING A NON-SHOCKABLE RHYTHM. DURING A SINGLE ANALYSIS PERIOD (THE 6TH SUCH PERIOD) APPROXIMATELY 12 MINUTES INTO THE RESCUE ATTEMPT, THE RESCUERS PERFORMED CPR DURING THE AED'S ANALYSIS PERIOD. CPR BEING PERFORMED DURING ANALYSIS CAN LEAD TO A FALSE SHOCK INDICATION AS IT DID IN THIS INSTANCE. IT IS FOR THIS REASON THE AED PROMPTS THE USER TO "DO NOT TOUCH THE PATIENT" DURING ANALYSIS PERIODS. ONCE THE AED BEGAN CHARGING AND THE RESCUERS CEASED PERFORMING CPR, THE ASYSTOLIC RHYTHM BECAME CLEARLY VISIBLE AND THE AED CORRECTLY CANCELLED SHOCK. WHEN THE AED WAS POWERED DOWN SEVERAL MINUTES LATER, THE AED WARNED THE USER TO REPLACE THE 9V BATTERY. THE AED PERFORMED CORRECTLY; NO MALFUNCTIONS ARE EVIDENT. THE AED IS PERFORMING AS DESIGNED AND CURRENTLY REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED BY AN END USER THAT DURING A RESCUE ATTEMPT BY COMPANY EMPLOYEES, THE AED ADVISED A SHOCK, BUT POWERED OFF, REPORTING REPLACE BATTERY PACK. IT WAS REPORTED THAT NO SHOCKS WERE DELIVERED AND THAT THE PATIENT WAS NOT RESUSCITATED. THE END USER REPORTED THAT THEY POWER ON THE AED OFTEN FOR TRAINING AND PERFORM BATTERY PACK SELF-TESTS FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448899 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death