BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 19479682 · Received June 6, 2024

    Report

    Report Number
    1220908-2024-02181
    Event Type
    Death
    Date Received
    June 6, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 27, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS B5 UPDATED, D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # JUSTIFICATION: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. EVALUATION: A ZOLL MEDICAL REPRESENTATIVE WENT ONSITE TO EVALUATE THE DEVICE AND THE CUSTOMER'S REPORT WAS OBSERVED IN THE DEVICE LOG AND ATTRIBUTED TO POOR COUPLING BETWEEN THE PATIENT'S SKIN AND ELECTRODE PADS. THE LOG REGISTERED AN INVALID IMPEDANCE BETWEEN 300-580 OHMS. IN ORDER FOR THE DEVICE TO SUCCESSFULLY REGISTER A "PADS ON" MESSAGE AND DISPLAY ECG SIGNAL, A VALID PATIENT IMPEDANCE BETWEEN 15-300 OHMS MUST BE READ. POOR COUPLING CAN OCCUR FOR MANY REASONS NOT INDICATING DEVICE MALFUNCTION, INCLUDING BUT NOT LIMITED TO, POOR PATIENT PREPARATION, IMPROPER ELECTRODE PLACEMENT, IMPROPER CONNECTION BETWEEN PADS AND MFC/ADAPTER, PATIENT MOVEMENT, OR PAD MOVEMENT DURING CPR. THE X SERIES IS DESIGNED PROVIDE AN AUDIBLE TONE WHEN THE CONNECTION IS LOST WITH A DISPLAYED MESSAGE OF "CHECK PADS" AND "PADS LEAD FAULT". THE PADS FROM THE EVENT WERE DISCARDED AND COULD NOT BE EVALUATED. THE MFC AND ROC ADAPTER WERE REPLACED AS PRECAUTION DURING THE INVESTIGATION. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS INTERMITTENTLY UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6161 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221111-06 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death