BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR (AA) ELECTRODE

    MDR report key: 1981365 · Received January 24, 2011

    Report

    Report Number
    1220908-2011-00184
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING AN (B)(4) MALE PT, THE STERNUM ELECTRODE SPARKED UPON DISCHARGE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONESTEP CPR (AA) ELECTRODE ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0217-01 2410

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death