BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONESTEP CPR AA

    MDR report key: 20854879 · Received December 5, 2024

    Report

    Report Number
    1218058-2024-00109
    Event Type
    Injury
    Date Received
    December 5, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS D4 LOT # AND EXPIRATION DATE UPDATED AND H4 MANUFACTURING DATE UPDATED. THE ONESTEP CPR ELECTRODES LOT 3624C WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. UPON INSPECTION, IT WAS OBSERVED THAT THE APEX AND STERNUM BOTH HAD STRANDS OF HAIR COVERING VARIOUS POHTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/D11.JSF#RTIONS OF THE FOAM WITH NO IRREGULARITIES OF NOTE. REVIEW OF THE MATERIAL REPORT LOG AND DHR FOR THE LOT FOUND NO ISSUES WITH THE PADS FROM LOT 3624C. IT IS IMPORTANT TO NOTE THAT DURING CARDIOVERSION THERAPY, PATIENTS CAN EXPERIENCE BURNS AND REDNESS DUE TO A HIGH MEASURED PATIENT IMPEDANCE. THIS COULD BE FOR A VARIETY OF REASONS INCLUDING, BUT NOT LIMITED TO, SKIN PREPARATION, ELECTRODE APPLICATION, OR POOR COUPLING. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 50-YEAR-OLD MALE PATIENT, SPARKS WERE EMITTED FROM THE ELECTRODES, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUFFERED BURNS. NO INFORMATION WAS AVAILABLE ON THE DEGREE OF BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085389 ONESTEP CPR AA ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0225-01 3624C 00847946016289

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other