BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 18876594 · Received March 11, 2024

    Report

    Report Number
    1220908-2024-00977
    Event Type
    Death
    Date Received
    March 11, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 1, 2024
    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

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION, INSTEAD THE CLINICAL FILE WAS RECEIVED. REVIEW OF THE CLINICAL FILE FROM THE REPORTED EVENT CONCLUDED THAT THE DEVICE WORKED AS DESIGNED AND WITHIN THE LIMITATIONS OF THE TECHNOLOGY. REVIEW OF THE CLINICAL FILE IDENTIFIED CONDITIONS THAT QUALIFY AS A SHOCKABLE EVENT SUCH AS CPR WAVEFORM COMPRESSIONS WERE CONTINUED THROUGHOUT THE ANALYSIS PERIOD WHICH INTRODUCED SIGNIFICANT ARTIFACT INTO THE ECG. THE PRESENCE OF THIS ARTIFACT OBSCURED THE UNDERLYING RHYTHM AND SHIFTED THE ANALYSIS RESULTS TO A "SHOCK ADVISED" RESULT. THIS CLAIM HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 74-YEAR-OLD FEMALE PATIENT ON FULL ADVANCED LIFE SUPPORT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVED WAS NON-SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010533 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death