BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE

    MDR report key: 24251232 · Received February 3, 2026

    Report

    Report Number
    3003521780-2026-00007
    Event Type
    Death
    Date Received
    February 3, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 2, 2026
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    00815098020003
    PMA / PMN Number
    P160032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE CUSTOMER REPORTED THAT THE AED ALERTED SERVICE CODE 5300 PRIOR TO THE RESCUE ON (B)(6) 2025, ANALYSIS OF THE LOG FILES DETERMINED THAT THE SERVICE CODE FIRST OCCURRED ON 01/02/26. THE ALERT WAS TRIGGERED DUE TO THE PADS USED DURING THE RESCUE BEING STUCK TOGETHER AFTER THE EVENT. LOG FILE ANALYSIS CONFIRMED A RESCUE EVENT ON (B)(6) 2025 LASTING 244 SECONDS, DURING WHICH NO SHOCKS WERE ADVISED OR DELIVERED. ALTHOUGH REQUESTED, THE AED HAS NOT BEEN RETURNED AND THE CAUSE OF THE COMPLAINT IS NOT KNOWN.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEY POWERED ON THEIR AED PRIOR TO A RESCUE ATTEMPT AND RECEIVED SERVICE CODE 5300. THE PADS WERE CONNECTED TO THE PATIENT; HOWEVER, THE AED CONTINUED TO ANNOUNCE "ANALYZING PATIENT" AND DID NOT PROGRESS BEYOND THAT MESSAGE. THE CUSTOMER REPORTED CPR WAS PERFORMED FOR APPROXIMATELY 45 MINUTES WITH THE USE OF AN AUTOMATED CARDIAC COMPRESSION DEVICE. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311623 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-100A 00815098020003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death