BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR STAT PADZ

    MDR report key: 4176774 · Received September 29, 2014

    Report

    Report Number
    1220908-2014-02429
    Event Type
    Death
    Date Received
    September 29, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP 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 WHILE ATTEMPTING TO TREAT A PT THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE RADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604673 CPR STAT PADZ ELETRODE MLN ZOLL MEDICAL CORPORATION 8900-0400 4813

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death