BEUDAMED
    FDA Adverse Event Other Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 2929383 · Received January 18, 2013

    Report

    Report Number
    9681860-2013-00001
    Event Type
    Other
    Date Received
    January 18, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 20, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE DEFIBRILLATION ELECTRODES RE 100% TESTED PRIOR TO RELEASE TO CONFIRM ELECTRICAL CONTINUITY. ALTHOUGH THE SPECIFIC DEFIB ELECTRODE IN QUESTION WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, WE HAVE REVIEWED THE COMPLAINT HISTORY AND THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE 1310P SINCE 2009. THERE HAVE BEEN NO NCR REPORTS FOR THE LAST 12 MONTHS REGARDING SHOCK DELIVERIES FOR ANY OF OUR AED PRODUCTS. THERE HAVE BEEN NO DESIGN CHANGES FOR THE AED PRODUCT FAMILY WITH RESPECT TO ELECTRICAL ENERGY PATHWAY. FOUR SAMPLES WERE RETURNED BY THE CUSTOMER FOR EVAL. THREE HAD BEEN OPENED AND ALLEGEDLY EXPERIENCED THE SAME "CONNECT ELECTRODE" ERROR MESSAGE. ONE ADD'L DEFIB ELECTRODE WAS RETURNED AND THE PACKAGE HAD NOT BEEN OPENED. TESTING ON THE FOUR RETURNED COVIDIEN 1310P DEFIB ELECTRODES WAS CONDUCTED PER INDUSTRY STANDARD FOR DEFIB ELECTRODES (ANSI/AAMI DF39). TESTING WAS PERFORMED AND PRODUCT WAS FOUND TO MEET THE REQUIREMENTS OF THIS STANDARD FOR ELECTRICAL PERFORMANCE. WE ARE CONTINUING OUR INVESTIGATION REGARDING THE MANNER IN WHICH THE ELECTRODES WERE USED (I.E. WERE THE PADS PROPERLY GROUNDED PRIOR TO USE ON THE PT AND DURING TESTING) AND REGARDING THE PERFORMANCE OF THE LIFEPACK 500 AED THAT WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DEFIBRILLATION ELECTRODE. THE CUSTOMER ADVISED THAT THEY WERE PAGED OUT FOR AN ELDERLY FEMALE WHO WAS UNCONSCIOUS. WHEN THE EMT ARRIVED ON SCENE, AN ELDERLY FEMALE WAS LAYING ON THE GROUND. THE CUSTOMER REPORTS THAT THE FEMALE WAS GETTING INTO HER CAR BECAUSE SHE DID NOT FEEL WELL AND COLLAPSED NEXT TO HER CAR. THE PT WAS NOT BREATHING AND HAD NO HEARTBEAT. THE EMT FIREFIGHTER ASSUMED PT CARE AND BEGAN CPR. THE EMT PLACED PADS ON THE PT TO DELIVER A SHOCK TO THE PT AND THE LIFEPACK 500 AED READ "CONNECT ELECTRODE." THE EMT TRIED GAIN WITH ANOTHER SET OF DEFIB PADS AND GOT THE SAME ERROR MESSAGE "CONNECT ELECTRODE." THE CUSTOMER STATED THAT THE LIFEPACK 500 AED WOULD NOT RECOGNIZE THE ELECTRODE AND THEREFORE WOULD NOT SHOCK THE PT. THE AMBULANCE ARRIVED ON THE SCENE AND THE FIREFIGHTER PULLED THE BACKBOARD FROM THE AMBULANCE. THE FIREFIGHTER ASSISTED IN PLACING THE PT ON THE BACKBOARD AND BRIEFED THE PARAMEDIC REGARDING THE PT'S CONDITION. THE CUSTOMER REPORTS THAT TWO FIREFIGHTERS CONTINUED CPR IN THE AMBULANCE AS THE PARAMEDIC SET UP AN IV. ONCE THE IV WAS ESTABLISHED BOTH FIREFIGHTERS RODE IN THE ASSIST WITH COMPRESSIONS. THE PT WAS TRANSPORTED TO THE HOSPITAL WHERE THE PT WAS PRONOUNCED DECEASED. THE SERIAL NUMBER OF THE LIFEPACK 500 AED MODEL IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27967 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION ELECTRODE MLN COVIDIEN 31319281 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other