BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 20689048 · Received November 14, 2024

    Report

    Report Number
    3003521780-2024-01255
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Report Date
    October 15, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020031
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS OF THE LOG FILES FROM AED SERIAL NUMBER (B)(6) SHOWS THAT THE AED WAS PLACED IN SERVICE ON 2021/06/30 WITH A DBP-1400 BATTERY PACK, SERIAL NUMBER (B)(6). ON 2024/06/14, THE AED REPORTED A SERVICE CODE THAT APPEARS TO BE ATTRIBUTED TO THE UNINTENTIONAL PRESSING OF THE AED BUTTONS WHILE THE UNIT WAS STORED. THE AED ATTEMPTED TO ALERT THE USER BY FLASHING ITS RED ASI AND CHIRPING. ON 2024/07/24, DURING A WEEKLY AUTOMATED SELF-TEST, THE AED REPORTED A SERVICE CODE ALONG WITH A "REPLACE BATTERY PACK NOW" WARNING, AS THE BATTERY PACK'S VOLTAGE HAD BECOME CRITICALLY LOW. ON (B)(6) 2024, THE AED WAS POWERED ON FOR AN EVENT LASTING 265 SECONDS, CONSISTING OF TWO ANALYSIS PERIODS AND ONE DEFIBRILLATION SHOCK. DURING THE EVENT, THE AED DETECTED A SHOCKABLE RHYTHM AND APPROPRIATELY ADVISED AND DELIVERED A SHOCK TO THE PATIENT. DURING THE SECOND ANALYSIS PERIOD, THE AED AGAIN DETECTED A SHOCKABLE RHYTHM; HOWEVER, DURING CHARGING, THE AED POWERED OFF DUE TO THE PREVIOUSLY REPORTED LOW BATTERY CONDITION. THE AED WAS IMMEDIATELY POWERED BACK ON FOR AN EVENT LASTING 52 SECONDS WITH ONE ANALYSIS PERIOD AND NO SHOCKS BEING ADVISED OR DELIVERED. DURING THIS PERIOD, THE AED IDENTIFIED A NON-SHOCKABLE RHYTHM AND DID NOT ADVISE A SHOCK. THE AED WAS THEN POWERED OFF BY THE USER TOWARDS THE END OF THE CPR PERIOD.

    Description of Event or Problem · 0

    AN INTERNATIONAL DISTRIBUTOR REPORTED THAT DURING AN INTERVENTION, THE AED DISPLAYED AN ERROR AND WAS IMMEDIATELY REPLACED ON-SITE WITH ANOTHER AED. UPON PERFORMING A MANUAL SELF-TEST AT THE LHL OFFICE, THE UNIT NOW REPORTS 'UNIT OK. THE EVENT DATE, NOR THE PATIENT'S OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169077 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100E 10815098020031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown