BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 4909551 · Received July 7, 2015

    Report

    Report Number
    1220908-2015-01812
    Event Type
    Death
    Date Received
    July 7, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 3, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECG DATA FILE FROM THE EVENT WAS RETURNED AND EVALUATED. THE CLINICAL DATA INDICATED THAT THE DEVICE WAS IN PACER MODE, WHICH PREVENTED THE DEVICE FROM SELECTING THE PADS LEAD. FURTHER CLARIFICATION FROM THE CUSTOMER INDICATED THAT THERE WAS SOME CONFUSION AND THE USER'S COULD NOT FIGURE OUT HOW TO DISABLE THE PACING FUNCTION. WITH THE DEVICE IN PACER MODE, THE SELECTION OF THE PADS LEAD WOULD NOT BE AVAILABLE. THE USER MUST SELECT "TURN PACER OFF" IN THE PACER SETTINGS MENU IN ORDER TO ACCESS THE PADS LEADS. FURTHER INFORMATION INDICATED THAT ONCE THE CLINICIANS OBTAINED ANOTHER DEVICE, UTILIZING THE SAME ELECTRODE PADS, THE ECG SIGNAL WAS PRESENT. THIS CONFIRMS NO DEFECTS WITH THE PADS OR COUPLING ISSUES BETWEEN THE PADS AND THE PATIENT'S SKIN. BASED ON OUR REVIEW OF THE DATA WE HAVE CONCLUDED THAT THE DEVICE PERFORMED TO SPECIFICATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION 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 TREAT A (B)(6) FEMALE PATIENT WITH VITAL SIGNS ABSENT, THE USER WAS UNABLE TO SELECT PADS TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440289 X SERIES MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death