BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR AA

    MDR report key: 23680187 · Received December 1, 2025

    Report

    Report Number
    1218058-2025-00188
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016289
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE REPORTED INCIDENT WOULD NOT PASS THE READINESS TEST OR THE MANUAL 30J TEST. BASED ON INVESTIGATION TESTING THE PADS WERE CONFIRMED TO BE DEFECTIVE (SHORTING BAR OPEN). THE PADS (8900-0225-01 LOT 1025) WERE SCRAPPED. THE CUSTOMER WAS SENT REPLACEMENT PADS. NO EMERGING TREND BASED ON SIMILAR REPORTS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT ELECTRODES. THE ELECTRODES HAVE NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED THE SELF-TEST USING THESE ONESTEP PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093176 ONESTEP CPR AA ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-0225-01 1025 00847946016289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown