BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 19948983 · Received August 9, 2024

    Report

    Report Number
    19948983
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ONESTEP CPR COMPLETE PADS FOR ZOLL DID NOT PASS TESTING ON ZOLL. CHARGE RN (REGISTERED NURSE) ATTEMPTED TO RECONNECT PADS TWICE FOR TESTING BUT REPORTED THAT IT DID NOT SEEM TO CLICK WELL INTO THE ZOLL. CHARGE RN TRIED WITH NEW SET OF PADS AND THOSE PADS PASSED TESTING. TESTED ON ZOLL 06-0071.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560617 ONESTEP AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION 8900-0224-01 1724 B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown