BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 9729705 · Received February 19, 2020

    Report

    Report Number
    1218058-2020-00010
    Event Type
    Death
    Date Received
    February 19, 2020
    Date of Event
    January 13, 2020
    Report Date
    January 29, 2020
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODES INVOLVED WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE ELECTRODES WERE STUCK TOGETHER WITH NO STYRENE LINER IN BETWEEN THEM. REVIEW OF THE ELECTRODES DID NOT FIND ANY ANOMALIES. THERE WAS NO EVIDENCE FOUND DURING OUR TESTING THAT SUGGESTS THE ADHESIVE HAD WEAKENED PRIOR TO REMOVING THE ELECTRODE FROM THE PACKAGING AND APPLYING ON THE PATIENT. AS EXPECTED, THE ADHESIVE FOAM WAS NO LONGER FOUND TO BE AGGRESSIVE AS IT HAS NOW BEEN EXPOSED TO AIR FOR AN EXTENDED TIME PERIOD AND WAS NOT APPLIED TO THE STYRENE WHEN RETURNED TO OUR FACILITY. HOWEVER, RETAINED SAMPLE TESTING PERFORMED INDICATED THAT ALL 20 SAMPLES TAKEN FROM THE RAW MATERIAL LOT PASSED THE ADHESIVE PEEL TESTING WITH NO FAULTS FOUND. BASED ON OUR TESTING AND THE RETAINED SAMPLING, THE ELECTRODES WERE DETERMINED TO BE ASSEMBLED ACCORDING TO SPECIFICATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193267 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 3119D 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death