BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21839985 · Received April 15, 2025

    Report

    Report Number
    1220908-2025-01417
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 25, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION; INSTEAD, A ZOLL REPRESENTATIVE WENT ON SITE TO EVALUATE THE REPORT. IT WAS DETERMINED THAT THE NEW WEAPONS DETECTION SYSTEMS WERE CAUSING INTERFERENCE WITH ECG READINGS. THE DEVICE WILL NOT BE RETURNED TO ZOLL MEDICAL CORPORATION. THE X SERIES OPERATOR'S GUIDE STATES: "EQUIPMENT SUCH AS ELECTROCAUTERY OR DIATHERMY EQUIPMENT, RFID READERS, ELECTRONIC ARTICLE SURVEILLANCE (EAS) SYSTEMS, OR METAL DETECTORS THAT EMIT STRONG RADIO FREQUENCY SIGNALS CAN CAUSE ELECTRICAL INTERFERENCE AND DISTORT THE ECG SIGNAL DISPLAYED BY THE MONITOR, THEREBY PREVENTING ACCURATE RHYTHM ANALYSIS. ENSURE ADEQUATE SEPARATION BETWEEN SUCH EMITTERS, THE DEVICE, AND THE PATIENT WHEN PERFORMING RHYTHM ANALYSIS." ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE AN 88-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM, LOCATED NEXT TO THE METAL DETECTOR. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117420 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2221510-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female