BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE, 8 PER CASE

    MDR report key: 4902740 · Received July 1, 2015

    Report

    Report Number
    1218058-2015-00034
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 10, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT ELECTRODES WERE RETURNED FOR EVALUATION AND A THOROUGH EVALUATION WAS PERFORMED AND NO ASSEMBLY OR PERFORMANCE ISSUES FOUND. VISUAL EXAMINATION OBSERVED A WIRE DETACHED FROM THE APEX PAD. STRANDS OF WIRE WERE STILL PRESENT WITHIN THE CRIMP. INDICATING THAT THE APEX WIRE WAS INADVERTENTLY PULLED OUT. BASED ON THE RESULTS, IT WAS CONCLUDED THAT THE CAUSE OF THE CUSTOMER REPORT WAS DUE TO MISHANDLING. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, A WIRE WAS OBSERVED TO BE LOOSE/TORN FROM THE ELECTRODE. COMPLAINANT INDICATED THAT WHILE THE CLINICIAN EXAMINED THE ELECTRODES PRIOR TO APPLYING THEM TO THE PT AND THERE WAS NO LOOSE/TORN WIRE OBSERVED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429734 ONE STEP COMPLETE ELECTRODE, 8 PER CASE ELECTRODE MKJ BIO-DETEK, INC. 8900-0214 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK