BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE

    MDR report key: 3893338 · Received February 11, 2014

    Report

    Report Number
    1220908-2014-00259
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE DISPLAYED A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91326 ONE STEP COMPLETE ELECTRODE ELECTRODE MKJ ZOLL MEDICAL CORPORATION 8900-0214 4813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA