BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE AED

    MDR report key: 4605107 · Received March 13, 2015

    Report

    Report Number
    3003521780-2015-00004
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 7, 2015
    Report Date
    February 12, 2015
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE EVENT RECORD REVEALS A PT WHOSE CARDIAC RHYTHM IS VENTRICULAR TACHYCARDIA IN A TORSADES DE POINTES-LIKE PATTERN, WHICH THE AED CORRECTLY RECOGNIZED, ADVISED A SHOCK, CHARGED IN PREPARATION FOR SHOCK, AND ENABLED THE SHOCK BUTTON. THE SHOCK BUTTON WAS NOT PRESSED FOR SEVERAL SECONDS. DURING THE PERIOD WHERE THE AED WAS WAITING FOR THE RESCUER TO PRESS THE SHOCK BUTTON, LARGE ARTIFACTS APPEAR IN THE ECG SIGNAL. IT IS NOT CLEAR FROM THE RECORD WHETHER THE ARTIFACTS WERE DUE TO PATIENT CONTACT/MOTION (CPR, CHECKING VITALS, TRANSPORT, ...) OR DUE TO SOME INTERNAL AED ISSUE. CONSEQUENTLY, THE AED CANCELLED SHOCK SINCE IT COULD NO LONGER CONFIRM THE PRESENCE OF A SHOCKABLE ARRHYTHMIA DUE TO THIS INTERFERENCE IN THE ECG SIGNAL. DURING A SUBSEQUENT ANALYSIS PERIOD, AGAIN THE AED CORRECTLY RECOGNIZED, ADVISED A SHOCK AND COMMENCED CHARGING IN PREPARATION FOR A SHOCK. SIMILAR TO THE FIRST ATTEMPT AT SHOCK DELIVERY, LARGE ARTIFACTS APPEAR IN THE ECG, HOWEVER THIS TIME THE ARTIFACTS STARTED OCCURRING WHILE THE AED WAS STILL CHARGING. AGAIN, THE AED CANCELLED THE SHOCK DUE TO THE INTERFERENCE IN THE ECG SIGNAL. OTHER THAN FOR THE ARTIFACTS IN THE PT'S ECG, THE AED APPEARS TO HAVE FUNCTIONED ACCORDING TO DESIGN. ALTHOUGH THE CAUSE FOR THE INTERFERENCE IN THE ECG SIGNAL COULD NOT BE DETERMINED, THIS MDR IS BEING SUBMITTED FOR THE RESULTING CANCELED SHOCKS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY REPORTED IN THE MDR. THE AED AND ACCESSORIES HAVE BEEN REQUESTED SO THEY CAN BE EVALUATED. AS OF (B)(6) 2015, NEITHER HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE AED AND BATTERY PACK ASSOCIATED WITH THIS EVENT WERE RECEIVED AND INSPECTED. VISUAL INSPECTION OF THE AED AND ITS INTERNAL CIRCUITRY DID NOT IDENTIFY A PROBLEM. FUNCTIONAL TESTING OF THE AED AND BATTERY, WHICH CONSISTED OF CONNECTING THE AED AND BATTERY TO A PT SIMULATOR, DID NOT IDENTIFY A FUNCTIONAL PROBLEM, AS THE DEVICES SUCCESSFULLY DELIVERED MULTIPLE DEFIBRILLATION SHOCKS, ALL WITHIN SPEC, TO THE SIMULATED PT. THE RESULTS OF THE INSPECTION DID NOT IDENTIFY A PROBLEM. THE RETURNED AED AND BATTERY PACK ARE FUNCTIONING PROPERLY AS DESIGNED. ALTHOUGH THE CAUSE OF THE ARTIFACTS IN THE PT'S ECC COULD NOT BE DETERMINED, THE INSPECTION OF THE RETURNED AED AND BATTERY DID NOT IDENTIFY A PROBLEM, AS THEY ARE FUNCTIONING PROPERLY AS DESIGNED. NO ADD'L TESTING IS PLANNED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED BY A CUSTOMER THAT ON (B)(6) 2015 A (B)(6) MALE WHO WAS PREPARING TO PERFORM ON STAGE COLLAPSED. THEY REPORTED THAT AN AED ANALYZED THE PT, ADVISED A SHOCK, CHARGED, AND A BATTERY PACK LOW WARNING WAS GIVEN. THEY ALSO REPORTED THAT EMS SHOCKED THE PT A COUPLE OF TIMES WITH THEIR AED AND THAT HE SURVIVED, BUT WAS IN THE HOSPITAL ON LIFE SUPPORT. THE CUSTOMER FURTHER REPORTED THAT HE THOUGHT THE AED'S ACTIVE STATUS INDICATOR LIGHT (ASI) WAS BLINKING GREEN PRIOR TO THE EVENT BUT KNOWS IT WAS BLINKING GREEN AFTER CHANGING THE AED'S 9-VOLT BATTERY THE DAY AFTER THE EVENT. EXAMINATION OF THE AED'S ELECTRONIC HISTORY RECORD REVEALS THAT THE AED HAD BEEN POORLY MAINTAINED WHICH RESULTED IN THE LOW BATTERY CONDITION REPORTED DURING THE RESCUE ATTEMPT AND CAUSED THE AED'S ASI LIGHT TO NOT BLINK GREEN FOR 3 1/2 YEARS PRIOR TO THE RESCUE ATTEMPT ON (B)(6) 2015 - INDICATING THAT THE BATTERY PACK WAS NOT INSTALLED., AED WAS DEFECTIVE, OR THE 9-VOLT BATTERY WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173751 LIFELINE AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening