BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE

    MDR report key: 1771851 · Received July 21, 2010

    Report

    Report Number
    1220908-2010-01859
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE ELECTRODES FAILED TO ALLOW THE ASSOCIATED DEFIBRILLATOR TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PT, WITH THE SAME DEFIBRILLATOR. 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
    1 ONE STEP COMPLETE ELECTRODE ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0214 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK