BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE AED

    MDR report key: 4962995 · Received July 31, 2015

    Report

    Report Number
    3003521780-2015-00011
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    February 26, 2015
    Report Date
    July 2, 2015
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE EVENT RECORD INDICATES THAT THE AED WAS POORLY MAINTAINED. THE AED FIRST INDICATED THAT THE 9-VOLT BATTERY THAT POWERS THE AED'S SELF-TEST SYSTEM NEEDED REPLACEMENT ON (B)(6) 2014 AT WHICH POINT THE AED BEGAN FLASHING RED AND PERIODICALLY CHIRPING. THE AED CONTINUED IN THIS WARNING CONDITION THROUGH (B)(6) 2014. AT THIS POINT THE 9V BATTERY HAD BECOME SO DEPLETED AS TO BE UNABLE TO SUSTAIN BLINKING AND CHIRPING. THERE IS NO EVIDENCE THAT ANY USER ATTEMPTED TO ASCERTAIN THE CONDITION OF THE AED AND TAKE ACTION. THE LACK OF A 9V BATTERY FOR OVER 7 MONTHS PRIOR TO THE RESCUE ATTEMPT PREVENTED THE AED FROM PERFORMING ITS REGULAR MAINTENANCE AND TEST PROCEDURES. ONE OF THE MOST IMPORTANT ASPECTS OF THESE SCHEDULE TESTS IS TO MAINTAIN THE PERFORMANCE OF THE PRIMARY BATTERY. ON (B)(6) 2015, THE ASSUMED RESCUE ATTEMPT, THE AED PROPERLY RECOGNIZED VF (A SHOCKABLE RHYTHM), HOWEVER, SOON AFTER COMMENCING CHARGE, THE BATTERY VOLTAGE BECAME SO LOW, DUE TO THE LACK OF MAINTENANCE, AS TO NOT BE ABLE TO SUSTAIN THE AED CONTROL SYSTEM. CONSEQUENTLY, THE CHARGING OPERATION ABORTED AND THE AED RESET. A SECOND RECORD IMMEDIATELY FOLLOWING, MIMICS THE FIRST RESCUE RECORD. NO OTHER EVENTS WERE RECORDED IN (B)(6) 25015. THIS MDR EVENT IS RELATED TO FAILURE TO MAINTAIN THE DEVICE PER THE MANUFACTURER'S REQUIREMENTS. SPECIFICALLY, WHEN THE AED IDENTIFIED AND ALERTED THE USER OF A PROBLEM, THE USE FAILED TO TAKE ACTION.

    Description of Event or Problem · 1

    ON 07/02/2015 IT WAS REPORTED BY A PROFESSIONAL USER THAT DURING A RESCUE ATTEMPT IN (B)(6) 2015 BY EMS, THE EXACT DATE WAS NOT KNOWN, THE AED POWERED OFF AND THAT THE PT WAS NOT RESUSCITATED. IT WAS ALSO REPORTED BY THE OFFICER THAT HE BELIEVES THE AED'S BATTERY WAS DEPLETED AND HAS SINCE REPLACED IT. WE REVIEWED THE PROPER MAINTENANCE OF THIS DEVICE WITH THE CUSTOMER AND VERIFIED THAT THE AED IS FUNCTIONING AS DESIGNED. THE UNIT CURRENTLY REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498979 LIFELINE AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death