BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE VIEW AED

    MDR report key: 4366295 · Received December 22, 2014

    Report

    Report Number
    3003521780-2014-00016
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    January 23, 2013
    Report Date
    November 20, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE CUSTOMER, THE RETURNED AED (WITH BATTERY PACK) WAS NOTED AS CHIRPING AND FLASHING ITS RED ACTIVE STATUS INDICATOR LIGHT, INDICATING THAT THE AED REQUIRES SERVICE. THE DEVICE WAS CONNECTED TO A PT SIMULATOR SET TO VENTRICULAR FIBRILLATION (A SHOCKABLE RHYTHM), THE AED ANALYZED THE RHYTHM, APPROPRIATELY ADVISED AND DELIVERED A DEFIBRILLATION SHOCK, WITHIN SPEC, TO THE SIMULATED PT. VISUAL INSPECTION OF THE DEVICE'S INTERNAL COMPONENTS DID NOT IDENTIFY A PROBLEM. THE INVESTIGATION REMAINS OPEN AND NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED BY A CUSTOMER THAT THEIR AED WAS REPORTING A SERVICE CODE AND THAT THIS SERVICE CODE DID NOT OCCUR DURING USE. WHILE REVIEWING THE DEVICE'S ELECTRONIC HISTORY AS PART OF THE INVESTIGATION INTO THE REPORTED SERVICE CODE, A POSSIBLE PT USE ON (B)(6) 2013 WAS NOTED WHERE THE PT'S ECG SIGNAL BECAME HEAVILY CORRUPTED WITH EITHER INTERFERENCE OR ARTIFACTS. THE PRECISE NATURE OR SOURCE OF THE INTERFERENCE OR ARTIFACTS IS UNCLEAR FROM THE ELECTRONIC HISTORY, THEREFORE, THIS MDR IS BEING FILED. NEITHER THIS DEVICE USE NOR ANY PRODUCT PROBLEMS ASSOCIATED WITH ITS USE WERE REPORTED AT THAT TIME. UPON REVIEW OF THIS EVENT WITH THE REPORTING INDIVIDUAL, HE INDICATED THAT HE REMEMBERED AN EVENT IN (B)(6) 2013 WHERE A MAN PASSED OUT AND THE AED WAS APPLIED, BUT HE REGAINED CONSCIOUSNESS AND THE AED WAS REMOVED WITHOUT BEING USED. NO ADD'L REPORTS OF THIS TYPE FOR THIS DEVICE ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843784 LIFELINE VIEW AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-A2300EN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK