BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 21365369 · Received February 12, 2025

    Report

    Report Number
    1218058-2025-00011
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 2, 2025
    Report Date
    January 22, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONESTEP ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. IT WAS OBSERVED THAT ONE OF THE ELECTRODES WAS APPLIED TO THE NONCOATED SIDE OF THE PACKAGING MAKING IT DIFFICULT TO BE REMOVED WITHOUT DAMAGE. THE DHR INVESTIGATION YEILDED NO SIMILAR NONCONFORMANCES AS PART OF THE ASSEMBLY PROCESS AND FINAL ASSEMBLY TESTING. WE WERE UNABLE TO CONFIRM WITH THE CUSTOMER IF THE ELECTRODES WERE REUSED OR REAPPLIED TO THE PACKAGING PRIOR TO USE IN THIS PATIENT EVENT. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 73-YEAR-OLD FEMALE PATIENT, THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845460 ONESTEP ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 2924K 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female