BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE AED

    MDR report key: 4908312 · Received July 9, 2015

    Report

    Report Number
    3003521780-2015-00009
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE EVENT RECORD INDICATES THAT ON (B)(6) 2014, THE 9-VOLT BATTERY THAT POWERS THE AED'S SELF-TEST SYSTEM BECAME DEPLETED. THE 9-VOLT BATTERY WAS NOT REPLACED AND THE AED SAT FOR APPROXIMATELY 7 MONTHS UNABLE TO PERFORM ITS' AUTOMATIC SELF-TESTS. ON (B)(6) 2015, THE 9-VOLT BATTERY WAS REPLACED AND WHEN THE BATTERY PACK (WITH THE REPLACEMENT 9-VOLT BATTERY) WAS INSERTED, INTO THE AED, IT PERFORMED AN AUTOMATIC BATTERY PACK SELF-TEST, REPORTED THE SERVICE CODE 1005 TO THE USER ON POWER DOWN AND BEGAN CHIRPING AND FLASHING ITS' RED ASI. THIS CONDITION WAS NOT ADDRESSED BY THE USER AND THE UNIT WAS RETURNED TO SERVICE WHERE IT WAS DEPLOYED SHORTLY THEREAFTER FOR THE REPORTED RESCUE ATTEMPT WHERE THE UNIT WOULD NOT POWER ON DUE TO THE PREVIOUSLY REPORTED CONDITION. 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 THE PROBLEM, THE USER FAILED TO TAKE ACTION. FURTHERMORE, THE DEPLETED 9-VOLT BATTERY PREVENTED THE AED FROM PERFORMING ITS DAILY SELF-TESTS FOR SEVERAL MONTHS.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED BY A PROFESSIONAL USER THAT WHEN EMS ARRIVED ON A SCENE WHERE A PATIENT WAS FOUND UNRESPONSIVE, THEY APPLIED THE AED PADS TO THE PATIENT, TURNED THE ED ON, AND THE UNIT POWERED OFF STATING A SERVICE CODE 1005 AND WOULD NOT POWER BACK ON. ALTHOUGH IT WS REPORTED THAT THE PATIENT WAS OT RESUSCITATED, THE INITIAL REPORTER STATED THAT HE FELT THE PATIENT MAY HAVE BEEN DECEASED BEFORE THEY ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446738 LIFELINE AED MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death