BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP COMPLETE ELECTRODE

    MDR report key: 2904733 · Received December 3, 2012

    Report

    Report Number
    1220908-2012-03262
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL 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 DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED ONESTEP COMPLETE ELECTRODE PADS. 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 ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0214 2112A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA