BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 15045462 · Received July 18, 2022

    Report

    Report Number
    1220908-2022-02601
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    June 23, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019259
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTION H6 (MEDICAL DEVICE PROBLEM CODE). DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE CUSTOMER'S REPORT OF DEFIB AND PACER FAILURE WAS DUPLICATED AND ATTRIBUTED TO THE PROCESSOR/BRIDGE/PACE BOARD. THE PROCESSOR/BRIDGE/PACE BOARD WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE REPORT OF NO SHOCK ADVISED WAS REVIEWED AND DETERMINED THE X SERIES PERFORMED AS DESIGNED AND WITHIN THE LIMITATIONS OF THE TECHNOLOGY AVAILABLE. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILATE A 59-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED SELF-TEST FOR DEFIB AND PACER FUNCTIONS AND DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 59-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED SELF-TEST FOR DEFIB AND GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333618 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946019259

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Death