BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 14704261 · Received June 15, 2022

    Report

    Report Number
    1218058-2022-00055
    Event Type
    Death
    Date Received
    June 15, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 25, 2022
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE AND ELECTRODE PADS HAVE NOT BEEN RETURNED TO ZOLL FOR EVALUATION. THE ELECTRODE PADS LOT NUMBER WAS NOT AVAILABLE, THEREFORE RETAINED SAMPLE TESTING COULD NOT BE PERFORMED. REVIEW OF THE INFORMATION PROVIDED BY THE COMPLAINANT, INDICATED THAT THE ELECTRODES WERE REPLACED THREE TIMES. TO IMPROVE COUPLING/ADHESION, THE INSTRUCTIONS FOR USE STATES FOR THE USER TO REMOVE EXCESS CHEST HAIR AND ENSURE THAT THE SKIN IS CLEAN AND DRY UNDERNEATH THE ELECTRODE PADS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 39-YEAR-OLD FEMALE PATIENT FOR CARDIAC ARREST, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED THREE DIFFERENT SETS OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132112 ELECTRODES, ONESTEP COMPLETE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ BIO-DETEK INCORPORATED 8900-0224-01 UNK 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Death