BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 24434481 · Received February 24, 2026

    Report

    Report Number
    3003521780-2026-00154
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 24, 2026
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    00815098020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE AED ELECTRONIC LOG FILES SHOW THAT PROLONGED UNATTENDED RED ASI AND LOW-BATTERY CONDITIONS, WITHOUT USER INTERVENTION, RESULTED IN BATTERY DEPLETION PRIOR TO THE REPORTED RESCUE EVENT. NO DEVICE MALFUNCTION WAS IDENTIFIED IN THE LOG DATA. ON (B)(6) 2025, THE AED DETECTED THAT THE ELECTRODE PADS WERE NOT CONNECTED AND BEGAN FLASHING ITS RED ACTIVE STATUS INDICATOR (ASI) WITH AUDIBLE CHIRPING TO ALERT THE USER. THE DEVICE CONTINUED TO DISPLAY THE RED ASI AND ISSUE PERIODIC AUDIBLE ALERTS TO PROMPT THE USER. ON (B)(6) 2025, THE AED DETECTED A LOW-BATTERY CONDITION AND CONTINUED RED ASI INDICATION AND AUDIBLE ALERTS. THE DEVICE REMAINED IN THIS ALERT STATE UNTIL (B)(6) 2025, WHEN THE BATTERY PACK BECAME FULLY DEPLETED. ELECTRONIC LOGS SHOW NO EVIDENCE OF USER INTERACTION OR CORRECTIVE ACTION (E.G., PAD RECONNECTION, BATTERY REPLACEMENT, OR SYSTEM CHECK) BETWEEN (B)(6) 2025 AND (B)(6) 2026, WHEN A REPLACEMENT BATTERY PACK WAS INSTALLED. THE REPORTED RESCUE EVENT OCCURRED ON 01/22/2026, DURING THE PERIOD WHEN THE DEVICE BATTERY WAS ALREADY FULLY DEPLETED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING AN RESCUE EVENT THEIR AED DID NOT POWER ON. CPR WAS PERFORMED. EMERGENCY MEDICAL SERVICES ARRIVED AND ASSUMED PATIENT CARE. A SECOND AED WAS APPLIED, AND DELIVERED A SHOCK. THE PATIENT DID NOT SURVIVE TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494183 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100A 00815098020003

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death