BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP BASIC ELECTRODE

    MDR report key: 2072051 · Received April 20, 2011

    Report

    Report Number
    1220908-2011-01040
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE 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
    1 ONESTEP BASIC ELECTRODE ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0211 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA