BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT PADZ ELECTRODES,

    MDR report key: 1150434 · Received September 3, 2008

    Report

    Report Number
    1220908-2008-02070
    Event Type
    Death
    Date Received
    September 3, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS REC'D THE PRODUCT, AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A MALE PT, A SMALL FIRE OCCURRED AT THE DEFIB PAD SITE WHEN ENERGY WAS DELIVERED. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED; HOWEVER, IT WAS NOT RELATED TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT PADZ ELECTRODES, ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-4003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death