BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS CORPATCH

    MDR report key: 4319670 · Received November 26, 2014

    Report

    Report Number
    8020045-2014-00016
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 25, 2014
    Report Date
    November 26, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ELECTRODE INVOLVED IN THE INCIDENT WAS 44 MONTH OLD AND HAD EXPIRED MORE THAN 20 MONTHS BEFORE, AN INVESTIGATION WAS STARTED. THE EXAMINATION OF RETAINED SAMPLES FROM THE SAME EXPIRED LOT DID NOT SHOW ANY LOSS OF ADHESION BUT DID NOT SHOW A DEGENERATION OF THE CONDUCTIVE METAL FILM OF THE ELECTRODE. WHEN A BACK-TO-BACK DEFIBRILLATION WAS PERFORMED ON A PAIR OF THESE RETAINED SAMPLES, ARCING WAS OBSERVED AND A SUBSEQUENT FAILURE. HOWEVER, IT CANNOT BE DETERMINED IF THE EXPIRED ELECTRODE USED FOR THIS PATIENT HAD THIS OBSERVED DEGENERATION AND IF SO, WHEN SUCH DEGENERATION MIGHT HAVE DEVELOPED. IN ANY CASE, THE LABEL OF THE INVOLVED ELECTRODE SET CLEARLY STATED JANUARY 2013 AS THE EXPIRATION DATE. AS A TRAINED OPERATOR HAD PUT THIS SET ON THE PATIENT IN (B)(6) 2014 AND SOME OTHERS RESPONSIBLE FOR RE-STOCKING OR STOCK CONTROL HAVE FAILED TO REMOVE IT BEFORE, WE ASSUME A USER ERROR CONTRIBUTED TO OR CAUSED THE EVENT. AN INTERNAL INVESTIGATION WAS STARTED TO DETERMINE IF A SIMILAR DEGENERATION COULD BE OBSERVED WITH OTHER PEDIATRIC MULTIFUNCTION ELECTRODE SETS BASED ON THE SAME ELECTRODE PADS. THE INVESTIGATION REVEALED THAT ELECTRODE SETS OF MORE THAN 2 YEARS OF AGE BUT WELL WITHIN THEIR SHELF LIFE OF UP TO 38 MONTHS CAN BE AFFECTED BY THE SAME DEGENERATION AND A RISK ARCING AND A RESULTING FAILURE EXISTS. AN IMMEDIATE RECALL OF ALL ELECTRODE MODELS POTENTIALLY AFFECTED AND OLDER THAN 18 MONTHS HAS BEEN INITIATED ON NOVEMBER 14TH. WE INTEND TO RECALL AFFECTED ELECTRODE SETS OF THESE MODELS (CURRENTLY 0-18 MONTHS OLD) REMAINING IN THE MARKET ON JANUARY 8TH AS THEY MAY SHOW THE OBSERVED DEGENERATION LATER IN THEIR SHELF LIFE (AFTER 24 MONTHS). THE INVESTIGATION FOR THE ROOT CAUSE IS STILL ONGOING. ALL FINDINGS WILL BE REPORTED IN ONE OR MORE F/U REPORTS. SETS WERE SHIPPED TO TWO CUSTOMER'S LOGISTIC CENTERS IN THE U.S. THE (B)(4) MARKET (ENSURED BY THEIR "UNRELEASE PRODUCT TRACKING" PROCEDURE) BUT HAVE BEEN EXCLUSIVELY RESHIPPED INTO (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) WE HAVE BEEN INFORMED OF AN INCIDENT INVOLVING PEDIATRIC MULTIFUNCTION DEFIBRILLATION ELECTRODES AND A CORPULS C3 DEFIBRILLATOR IN ((B)(6), EMERGENCY VEHICLE). MOST LIKELY ON (B)(6) 2014, IT WAS ATTEMPTED TO DEFIBRILLATE A (B(B)(6) 2013. THE USER DEFIBRILLATED ONCE. AFTER THE FIRST SHOCK ECG MONITORING WAS NO LONGER POSSIBLE AND NO FURTHER DEFIBRILLATION WAS POSSIBLE. THE PATIENT DIED. WE HAVE INQUIRED FOR MORE DETAILS ON THE INCIDENT AND THE PATIENT BUT HAVE SO FAR NOT RECEIVED ANY ADDITIONAL INFO. LATER A REP OF THE DISTRIBUTOR OPENED SOME MORE PACKAGES OF THE EXPIRED ELECTRODES LOT DURING A VISIT THERE. HE OBSERVED POOR ADHESION ("(B)(6)"). THE REP ASSUMED THAT THE EXPIRED ELECTRODES HAD DRIED OUT AND ASKED, IF A DRY-OUT COULD BE RESPONSIBLE FOR THE OBSERVED FAILURE. NEITHER THE CORPULS C3 DEFIBRILLATOR NOR THE ELECTRODES USED (DF60) ARE SOLD IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769650 GS CORPATCH MULTIFUNCTION DEFIBRILLATION ELECTRO MKJ LEONHARD LANG GMBH DF60 10127-0773

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other