BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 17884970 · Received October 6, 2023

    Report

    Report Number
    1220908-2023-03793
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 8, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019143
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS B5 AND H6: DEVICE PROBLEM CODE. THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED AND ATTRIBUTED TO SLIGHTLY LOOSE BATTERY KEP NUTS IN CONJUNCTION WITH A BATTERY APPROACHING DEPLETION, THE KEP NUTS WERE REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AFTER FOUR SUCCESSFUL SHOCKS, ON THE FIFTH ATTEMPT, THE DEVICE INTERNALLY DUMPED THE ENERGY AFTER CHARGING UP TO DEFIBRILLATE THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AFTER FOUR SUCCESSFUL SHOCKS, ON THE FIFTH ATTEMPT, THE DEVICE DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE. 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
    219028 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2221011-01 NA 00847946019143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown