BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8900-000251-05

    MDR report key: 18266266 · Received December 5, 2023

    Report

    Report Number
    1218058-2023-00166
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Report Date
    November 14, 2023
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 1218058-2023-00154. EVALUATION: THE ONESTEP CPR PADS WERE RETURNED TO ZOLL MEDICAL UNITED KINGDOM FOR EVALUATION. THE CUSTOMER'S REPORT WAS DUPLICATED DURING EVALUATION. THE REPORT WAS ATTRIBUTED TO A DISCONNECTED JUMPER WIRE (SELF TEST WIRE) ON THE ELECTRODE PAD. THIS TYPE OF FAILURE DOES NOT DISABLE THE ELECTRODE FROM DELIVERING THERAPY WHEN ATTACHED TO A DEFIBRILLATOR. THIS IS A MALFUNCTION WHICH ONLY IMPACTS SELF-TEST OF THE ELECTRODE WITH THE DEFIBRILLATOR. THIS TYPE OF MALFUNCTION DOES NOT POSE ANY CLINICAL IMPACT AND DOES NOT MEET OUR GUIDELINES FOR REPORTABILITY. THE ONESTEP CPR PADS WERE SCRAPPED AFTER EVALUATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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

    THIS SUPPLEMENTAL MEDWATCH REPORT CORRECTS INFORMATION SUBMITTED IN THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS: D1 BRAND NAME UPDATED, D4 CATALOG # REMOVED, AND D4 PRIMARY UDI # UPDATED. JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065345 8900-000251-05 ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-000251-05 2423A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown