BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 17754162 · Received September 15, 2023

    Report

    Report Number
    1220908-2023-03682
    Event Type
    Death
    Date Received
    September 15, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SECTION B5 AND H6 (DEVICE PROBLEM CODE). EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL UNITED KINGDOM FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING, SHOCK AND SYNC TESTING USING THE CUSTOMER'S RETURNED MULTIFUNCTION CABLE (MFC) AND CPR ADAPTOR WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE MFC AND CPR ADAPTOR WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) DURING CARDIAC ARREST, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) DURING CARDIAC ARREST, THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330965 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death