BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 5648495 · Received May 11, 2016

    Report

    Report Number
    3003521780-2016-00002
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    PMA / PMN Number
    K113787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 5-5-2016 WE RECEIVED THE AED (S/N (B)(4)) BATTERY PACK (S/N (B)(4)) AND A SET OF NEW, UNOPENED DEFIBRILLATION ELECTRODES (L/N D033115-01). WHEN THE CUSTOMER WAS ASKED ABOUT RETURNING THE PADS THAT WERE USED DURING THE TESTING, WE WERE INFORMED THAT THEY DO NOT USE PADS DURING TESTING. THEY STATED THAT WHEN THEY TESTED THE AED, THEY CUT THE CABLES FROM EXPIRED PADS AND CONNECTED THE CABLES TO THE PATIENT SIMULATOR WITH ALLIGATOR CLIPS. THE RETURNED AED AND BATTERY PACK WERE TESTED MULTIPLE TIMES IN THE FOLLOWING SIMULATED USE SCENARIO. THE AED, BATTERY PACK AND A SET OF TEST PADS WERE CONNECTED TO A PATIENT SIMULATOR SET TO VENTRICULAR FIBRILLATION (A SHOCKABLE RHYTHM). IN ALL CASES, THE AED ANALYZED THE ECG HEART RHYTHM, MADE AN APPROPRIATE SHOCK DECISION, CHARGED, IN PREPARATION FOR SHOCK DELIVERY, AND DELIVERED A DEFIBRILLATION SHOCK, WITHIN SPECIFICATION, TO THE SIMULATED PATIENT. THE AED'S PATIENT CONNECTOR WHICH CONNECTS THE PADS TO THE AED WAS DIMENSIONALLY INSPECTED AND FOUND TO BE WITHIN SPECIFICATION. THE AED WAS OPENED AND ALL THE CONNECTIONS FROM THE CIRCUIT BOARD TO THE PATIENT CONNECTOR WERE INSPECTED FOR DAMAGE, PROPER CONNECTIONS, AND CONTAMINATES AND ALL WERE OK. THE RESULTS OF THE VISUAL, FUNCTIONAL, DIMENSIONAL AND SIMULATED USE TESTS INDICATE THAT THE AED IS WITHIN SPECIFICATION AND FUNCTIONING PROPERLY AS DESIGNED. ALTHOUGH THE CAUSE OF THE INTERMITTENT CONNECTION COULD NOT BE DETERMINED, IT IS POSSIBLE THE INTERMITTENT CONNECTION WAS CAUSED BY AN ISSUE WITH THE CUSTOMER'S TEST SET-UP OR DUE TO THE PADS CONNECTOR NOT BEING COMPLETELY PLUGGED INTO THE AED. BASED ON THE ANALYSIS OF THE AED'S ELECTRONIC HISTORY, ALONG WITH THE RESULTS OF THE INSPECTION AND TESTING OF THE AED, IT IS BELIEVED THAT THE CAUSE OF THIS EVENT WAS RELATED TO FAILURE OF THE USER TO MAINTAIN THE DEVICE. SPECIFICALLY, THERE IS NO EVIDENCE THAT THE USER ATTEMPTED TO ASCERTAIN THE CONDITION OF THE AED AND TAKE ACTION WHEN PROMPTED BY THE DEVICE, EITHER PRIOR TO, AND AT THE TIME OF THE SIMULATED USE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY TESTED THEIR AED WITH A PATIENT SIMULATOR WHILE THE AED WAS FLASHING ITS RED ACTIVE STATUS INDICATOR (ASI) LIGHT, INDICATING A PROBLEM WITH THE AED. THE CUSTOMER REPORTED THAT DURING TESTING, THE AED ADVISED A SHOCK, BUT NO SHOCK WAS DELIVERED. THE CUSTOMER FURTHER REPORTED THAT AFTER TESTING, THE ASI WAS FLASHING GREEN. A REVIEW OF THE ELECTRONIC DATA FROM THIS AED SHOWS THE AED DETECTED A "NO PADS" CONDITION ON (B)(6)-2016 DURING AN AUTOMATIC DAILY SELF-TEST AND ATTEMPTED TO NOTIFY THE USER OF THIS ISSUE BY FLASHING ITS RED ASI LIGHT AND CHIRPING. THERE IS NO EVIDENCE IN THE ELECTRONIC DATA THAT ANY USER ATTEMPTED TO ASCERTAIN THE CONDITION OF THE AED AND TAKE ACTION. THE "NO PADS" CONDITION PERSISTED AND ON (B)(6)-2016, SIX DAYS LATER, WHILE STILL INDICATING A PROBLEM, THE AED WAS CONNECTED TO A PATIENT SIMULATOR AND TESTED. DURING TESTING, THERE WERE MULTIPLE INSTANCES WHERE THE IMPEDANCE OF THE SIMULATOR WAS MEASURING PROPERLY, THEN APPEARED OPEN; SUGGESTING A POSSIBLE INTERMITTENT CONNECTION ISSUE WITH THE PADS TO THE AED - THE CONDITION THAT THE UNIT HAD PREVIOUSLY WARNED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304151 LIFELINE AUTOMATED EXTERNAL DEFIBRILATOR MKJ DEFIBTECH, L.L.C. DDU-120A

    Patients

    Seq Age Sex Outcome Treatment
    1