BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 17700779 · Received September 7, 2023

    Report

    Report Number
    1220908-2023-03524
    Event Type
    Death
    Date Received
    September 7, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE CLINICAL FILE AND THE DEVICE PERFORMED TO SPECIFICATION. REVIEW OF THE CLINICAL FILE INDICATE THAT THE END USER INITIALLY HAD TROUBLE ACQUIRING A HIGH-QUALITY ECG SIGNAL. HOWEVER, THE PATIENTS ECG RHYTHM IS EVENTUALLY OBTAINED, AND THE DEVICE CAN ANALYZE AND DELIVER ENERGY. THIS INDICATES THE DEVICE CAN PERFORM ALL ESSENTIAL FUNCTIONS ONCE ALL CRITERIA HAVE BEEN MET. THE LOGS, AND STATEMENTS FROM THE END USERS SUGGEST THAT POOR COUPLING WAS THE CAUSE OF THE LACK OF ECG SIGNAL. ONCE THE COUPLING WAS IMPROVED, A SIGNAL WAS DISPLAYED, AND THE DEVICE CAPABLE OF ADMINISTERING THERAPY. IT IS NOTEWORTHY TO MENTION, THE X SERIES OPERATOR'S GUIDE STATES: PREPARING THE PATIENT FOR ELECTRODE APPLICATION: THE PROPER APPLICATION OF ELECTRODES IS ESSENTIAL FOR HIGH QUALITY ECG MONITORING. GOOD CONTACT BETWEEN THE ELECTRODES AND SKIN MINIMIZES MOTION ARTIFACT AND SIGNAL INTERFERENCE. BEFORE APPLYING THE ELECTRODES, PREPARE THE PATIENT'S SKIN, AS NECESSARY, SHAVE OR CLIP OFF EXCESS HAIR AT ELECTRODE SITE, CLEAN OILY SKIN WITH AN ALCOHOL PAD, AND RUB SITE BRISKLY TO DRY. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    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 SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293082 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death