BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONESTEP

    MDR report key: 21604451 · Received March 14, 2025

    Report

    Report Number
    21604451
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 10, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LIX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INCIDENT OCCURRED [REDACTED] IN THE ED [EMERGENCY DEPARTMENT]. PATIENT WAS IN UNSTABLE SVT [SUPRAVENTRICULAR TACHYCARDIA] IN THE 210 RATE. TRANSLUCENT PAD 8900-004041-01 APPLIED FIRST, BUT REMOVED DUE TO A STAFF MEMBER SAYING IT WAS THE WRONG PAD. THE ONE STEP PAD 8900-0224-01 WAS THEN APPLIED AND STAFF DELIVERED FIRST CARDIOVERSION. A SECOND CARDIOVERSION DELIVERED AND ARC'D. BURNS NOTED TO PATIENT'S CHEST AND PAD WAS REMOVED. A TRANSLUSCENT PAD WAS APPLIED FOR THE THIRD CARDIOVERSION. NO RHYTHM CHANGED AND REQUESTED CONSULT TO CARDIOLOGY. PATIENT RECEIVED SEDATION FOR CARDIOVERSIONS WHILE AWAITING CARDIOLOGY TEAM (5-15 MINUTES). PATIENT CODES AND A ONE STEP PAD WAS APPLIED. CPR STARTED ON FEEDBACK PORTION OF PAD. TECH REPORTS THAT IT WAS SLIDING SO HE REMOVED THE "PUCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104414 ONESTEP AID, CARDIOPULMONARY RESUSCITATION LIX ZOLL MEDICAL CORPORATION 8900-0224-01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male