BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT PATZ ELECTRODES

    MDR report key: 1491801 · Received October 1, 2009

    Report

    Report Number
    1220908-2009-02637
    Event Type
    Death
    Date Received
    October 1, 2009
    Date of Event
    September 2, 2009
    Report Date
    September 11, 2009
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STAT PADZ LOT NUMBER 0109B WAS MANUFACTURED ON JANUARY 1, 2009 AND EXPIRE ON JANUARY 1, 2011 AND STAT PATZ LOT NUMBER 2609 WAS MANUFACTURED ON JUNE 25, 2009 AND EXPIRE ON JUNE 25, 2011. ZOLL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT, WHO WAS IN CARDIAC ARREST, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE. THE CLINICIAN SWITCHED THE DEVICE TO MONITOR MODE, REMOVED THE STAT PADZ FROM THE PATIENT AND FELT A RESIDUAL CHARGE WHEN THE PADZ WERE REMOVED. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF STAT PADZ TO CONTINUE TREATING THE PATIENT, AND SUCCESSFULLY DELIVERED A SHOCK TO THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT PATZ ELECTRODES ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-4003 0109B/2609

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death