BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 21996979 · Received May 9, 2025

    Report

    Report Number
    1220908-2025-01552
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 18, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS. ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE, MULTIFUNCTION CABLE, AND BATTERY WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE RETURNED BATTERY WAS NOT THE BATTERY USED DURING THE EVENT. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE X SERIES OPERATOR'S GUIDE (PN: 9650-002355-01) (REV: G) INSTRUCTS THE USER TO "ALWAYS CARRY AT LEAST ONE FULLY CHARGED SPARE BATTERY. IF NO OTHER SOURCE OF BACK-UP POWER IS AVAILABLE, TWO SPARE BATTERIES ARE ADVISABLE.? 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 DEFIBRILLATE A PATIENT IN CARDIAC ARREST (AGE & GENDER UNKNOWN), THE DEVICE TOOK AN EXTENDED TIME TO CHARGE ENERGY. THE CLINICIAN WAS ABLE TO SUCCESSFULLY CHARGE AND ADMINISTER A SHOCK TO THE PATIENT. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969110 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2241411-01-66 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown