BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 15660093 · Received October 24, 2022

    Report

    Report Number
    1220908-2022-04000
    Event Type
    Death
    Date Received
    October 24, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 3, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946020491
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    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

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DATA FILE OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE DATA FILE INDICATED THE CUSTOMER REMAINED IN LEAD II VIEW. HAD THE CUSTOMER MANUALLY SWITCHED TO PADS VIEW OR PRESSED A DEFIB RELATED KEY SUCH AS "ANALYZE" OR "ENERGY SELECT", THE DEVICE WOULD HAVE DISPLAYED AN ECG SIGNAL IN PADS VIEW. 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 TREAT A 66-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028853 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946020491

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death