BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 4342197 · Received December 12, 2014

    Report

    Report Number
    3003521780-2014-00015
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 14, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12-3-2014 THE AED, BATTERY PACK AND PADS FROM THE REPORTED EVENT WERE RECEIVED. AS RECEIVED, THE AED'S ACTIVE STATUS INDICATOR (ASI) LIGHT WAS FLASHING RED AND THE AED WAS CHIRPING - REPORTING "BATTERY PACK LOW". A BATTERY PACK LOW PROMPT INDICATES THAT THE AED'S MAIN BATTERY PACK IS GETTING LOW. THE AED WILL STILL DELIVER SHOCKS, BUT THE USER SHOULD REPLACE THE BATTERY PACK AS SOON AS POSSIBLE. IN AS RECEIVED CONDITION, THE RETURNED AED AND BATTERY PACK WERE CONNECTED TO A PATIENT SIMULATOR SET TO VENTRICULAR FIBRILLATION (A SHOCKABLE RHYTHM), THE AED ANALYZED THE SIMULATED PATIENT'S HEART DELIVERED THE DEFIBRILLATION SHOCK, WITHIN SPECS, TO THE SIMULATED PATIENT. THE AED THEN SUCCESSFULLY DELIVERED THE DEFIBRILLATION SHOCK, WITHIN SPECS, TO THE SIMULATED PATIENT. THE AED THEN SUCCESSFULLY DELIVERED THE DEFIBRILLATION SHOCK, WITHIN SPECS, TO THE PATIENT TWO ADDITIONAL TIMES. AS RECEIVED, THE DEVICE FUNCTIONED APPROPRIATELY AS DESIGNED. BASED ON THE INVESTIGATION, IT IS BELIEVED THAT THE EVENT WAS CAUSED BY USER ERROR. SPECIFICALLY, THE AED'S MAIN BATTERY PACK WAS NOT MAINTAINED PER THE MANUFACTURER'S RECOMMENDATIONS AND THE AED WAS NOT POWERED ON LONG ENOUGH FOR IT TO ANALYZE THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED BY AN EMS DEPARTMENT THAT THE BATTERY PACK FOR THE AED IS LOW AFTER THREE YEARS AND THAT DURING A RESCUE ATTEMPT THE AED CHARGED, WOULD NOT SHOCK AND THEN TURNED OFF. NO PATIENT...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813827 LIFELINE AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A-EN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK