BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE

    MDR report key: 1952360 · Received January 3, 2011

    Report

    Report Number
    1220908-2010-03737
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Report Date
    December 14, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PT, THE COMPLAINANT WAS ABLE TO ATTACH THE ONE STEP ELECTRODE TO THE ASSOCIATED DEFIBRILLATOR UPSIDE DOWN. 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