BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP COMPLETE ELECTRODES

    MDR report key: 6969980 · Received October 23, 2017

    Report

    Report Number
    1218058-2017-00116
    Event Type
    Death
    Date Received
    October 23, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 2, 2017
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE THREE SETS OF ELECTRODES USED WERE RECEIVED FOR EVALUATION. THE ORDER OF USE COULD NOT BE DETERMINED. DUE TO THE STATE THAT THE ELECTRODES WERE RECEIVED IN, A DETERMINATION AS TO THE PROPER ASSEMBLY AND ADHESION QUALITIES OF THE CONDUCTIVE GEL AND ADHESIVE FOAM COULD NOT BE MADE. THE CUSTOMER'S REMAINING STOCK OF THE SUSPECTED LOTS WERE FORWARDED TO ZOLL FOR EVALUATION. ADDITIONALLY 35 SETS OF ELECTRODES FROM ZOLL'S FINISHED GOODS AREA WERE TESTED. THE ELECTRODE WERE TESTED SIMULATING 2015 AHA GUIDELINES AT VARIOUS LENGTHS OF TIME WITH THE ELECTRODES ATTACHED TO A MANIKIN IN CONFIGURATIONS IDENTIFIED IN THE IFU. THIS TEST WAS REPEATED USING THE 35 SETS OF ELECTRODES RETURNED FROM THE CUSTOMER. THERE WERE NO IDENTIFIED DIFFERENCES BETWEEN THE LOTS PULLED FROM FINISHED GOODS AND THE LOTS RETURNED FROM THE CUSTOMER. THERE WERE NO ABNORMALITIES, NON-CONFORMANCES, GEL ROLLING OR ELECTRODES SLIDING OBSERVED DURING OUR TESTING. THIS INVESTIGATION PROMPTED AN ONSITE VISIT BY ZOLL'S CLINICAL TEAM TO THE CUSTOMER'S SITE. THE FINDINGS WERE THAT THE STAFF DOES NOT FEEL THEIR CLINICAL TEAMS HAVE THE APPORPRIATE LEVEL OF DEVICE KNOWLEDGE. OBSERVATIONS INCLUDED STAFF REMOVING THE ELECTRODES INCORRECTLY FROM THE RELEASE LINER, NOT SEPARATING THE PADS FROM THE CENTRAL WIRING, NOT UNDERSTANDING THAT THE PUCK CAN BE REMOVED FROM IT'S ORIGINAL LOCATION, AND APPLYING ELECTRODES WITH ONLY THE GEL PORTION OF THE SKIN WITH THE FOAM EDGES OFF THE SKIN. HOWEVER, BASED ON OUR INVESTIGATION RESULTS, A DEFINITIVE DETERMINATION COULD NOT BE MADE AS TO WHY THE GEL WAS ROLLING AND SLIDING WHILE IN CLINICAL USE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE PERFORMING CPR ON A (B)(6) MALE PATIENT IN CARDIAC ARREST, THE ELECTRODE PADS WOULD SLIP OUT OF POSITION ON THE PATIENT'S CHEST AND WOULD NOT ADHERE APPROPRIATELY. COMPLAINANT INDICATED THAT THE ELECTRODE PADS WERE REPLACED THREE TIMES TO CONTINUE TREATING THE PATIENT, AND THE PATIENT WAS SUCCESSFULLY SHOCKED. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749270 ONE STEP COMPLETE ELECTRODES ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 3817 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death