BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR AA

    MDR report key: 23656517 · Received November 26, 2025

    Report

    Report Number
    1218058-2025-00187
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A RETAINED SAMPLE EVALUATION WAS CONDUCTED FOR THE ON-ESTEP CPR A/A ELECTRODES P/N 8900-0217-01, LOT 3425A, AFTER THE RETURNED ELECTRODES WERE REPORTEDLY LOST IN SHIPMENT. INSPECTION OF THE RETAINED SAMPLE FOUND NO DISCRPANCIES WITH PAD ASSEMBLY OR ADHESION TO THE STYRENE, AND ALL TESTING MET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY (DHR) IDENTIFIED NO NONCONFORMANCES RELATED TO ELECTRODE ADHESION FOR THIS LOT. THE ABILITY TO REMOVE ELECTRODES FROM THE STYRENE IS 100% TESTED DURING MANUFACTURING. IT IS POSSIBLE THE PADS WERE REMOVED FROM THE STYRENE PRIOR TO PATIENT USE AND REAPPLIED TO THE INCORRECT SIDE; HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT THE RETURNED ELECTRODES FOR EVALUATION. 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137924 ONESTEP CPR AA ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0225-01 3425A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown