BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 4928485 · Received July 15, 2015

    Report

    Report Number
    1218058-2015-00037
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    June 24, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE ELECTRODES. THE ELECTRODES WERE NOT RETURNED TO ZOLL FOR EVALUATION. AN EVALUATION OF THE RETAINED SAMPLE FROM THIS LOT DID NOT FIND ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE TREATING A PT, THE ELECTRODE PADS WERE NOT MAKING SUFFICIENT CONTACT, AND AN ARC WAS SEEN UPON DISCHARGE. COMPLAINANT INDICATED THAT A THIRD SET OF PADS WERE OBTAINED TO TREAT THE PT. PLEASE REFERENCE MEDWATCH REPORT 1218058-2015-00038 FOR THE SECOND REPORT. 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
    461009 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK, INC. 8900-0224-01 0215A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK