BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE, 8 PER CASE

    MDR report key: 1836746 · Received September 9, 2010

    Report

    Report Number
    1220908-2010-02654
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ELECTRODE PACKAGING DID NOT OPEN CORRECTLY AND CAUSED THEM TO STICK TOGETHER. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP COMPLETE ELECTRODE, 8 PER CASE ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0214 0310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA