BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 24188572 · Received January 27, 2026

    Report

    Report Number
    24188572
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 15, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING COMPRESSIONS MULTIPLE CPR PADS HAD TO BE USED AS THEY WERE NOT STICKING TO PATIENT. PATIENT WAS NOT DIAPHORETIC. PAD LOT #'S USED ARE: 1. LOT #4025B REF 8900-0224-01 (EACH) 8900-0214-01 (CASE OF 8) EXP 10/04/2027, 2. LOT #3425K REF 8900-0224-01 (EACH) 8900-0214-01 (CASE OF 8) EXP 08/23/2027, 3. LOT #4125E REF 8900-00224-01 (EACH) 8900-0214-01 (CASE OF 8) EXP 10/11/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249985 ONESTEP AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION 8900-0224-01, 8900-0214-01 4025B, 3425K, 4125E

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown