BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 3769548 · Received April 16, 2014

    Report

    Report Number
    3003521780-2014-00010
    Event Type
    Death
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY FROM THE AED IDENTIFIED THAT IT WAS PLACED IN SERVICE ON (B)(4) 2013 AND WAS FUNCTIONING PROPERLY, SUCCESSFULLY PERFORMING ITS SELF-TESTS WITH NO OCCURRENCES OF A SERVICE CODE OR WARNING INDICATING A UNIT MALFUNCTION. AN EVENT WAS RECORDED ON (B)(4) 2014 LASTING 29 SECONDS WHERE THE PADS WERE ATTACHED TO THE PT, THE AED WAS POWERED, THE AED BEGAN ANALYSIS OF THE PT, BUT THE ANALYSIS WAS INTERRUPTED DUE TO DRAMATIC SHIFTS IN THE ECG BASELINE WHICH THE AED ATTRIBUTED TO PT MOTION. THE AED INFORMED THE USER VIA A VOICE PROMPT SAYING "ANALYZING HEART RHYTHM, DO NOT TOUCH THE PT." THIS SEQUENCE REPEATED TWO ADD'L TIMES BEFORE THE AED WAS POWERED OFF BY THE USER. THE ECG AVAILABLE FROM THE EVENT WAS REVIEWED AND SHOWS SIGNIFICANT INTERFERENCE AND NO ADD'L CONCLUSIONS CAN BE MADE. BASED ON THIS REVIEW OF THE AED'S ELECTRONIC HISTORY, DETAILS FROM THE END CUSTOMER, AND DISCUSSIONS WITH THE RESCUER, THE CAUSE OF THE SHIFTS IN THE ECG BASELINE COULD NOT BE DETERMINED. THE ACTUAL DEVICE, BATTERY PACK AND DEFIBRILLATION PADS WERE REQUESTED IN ORDER TO AIDE IN THE INVESTIGATION. TO DATE, NEITHER THE AED, BATTERY PACK OR DEFIBRILLATION PADS ASSOCIATED WITH THIS COMPLAINT HAVE BEEN REC'D. THE INVESTIGATION IS CURRENTLY IN PROCESS. BASED ON THE OUTCOME OF THE INVESTIGATION, SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, AN AED WAS DEPLOYED ON A PT AND THE AED KEPT SAYING "ANALYZING, DO NOT TOUCH THE PT." POLICE, EMS AND FIRE PROFESSIONALS WERE ALL AT THE SCENE DURING THE USE. DURING F/U, IT WAS REPORTED THAT THE AED ALSO KEPT SAYING "MOTION DETECTED" AND THAT AFTER 29 SECONDS, THE AED WAS POWERED OFF. IT WAS ALSO REPORTED THAT A SECOND AED WAS DEPLOYED, WHICH DETECTED A SHOCKABLE RHYTHM HOWEVER, THE PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233447 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILALTOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death