BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 19343429 · Received May 17, 2024

    Report

    Report Number
    1220908-2024-01872
    Event Type
    Death
    Date Received
    May 17, 2024
    Date of Event
    May 5, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 SECTIONS D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # JUSTIFICATION FOR NO UDI: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. THE DEVICE AND MULTIFUNCTION CABLE (MFC) WERE RETURNED TO ZOLL MEDICAL CANADA FOR EVALUATION. THE CUSTOMER'S REPORT OF "THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS" AND DISPLAYED A "CABLE FAULT" MESSAGE WAS OBSERVED DURING REVIEW OF THE DEVICE LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE MFC AND DEFIB RECEPTACLE WERE REPLACED AS A PRECAUTION. THE CUSTOMER'S REPORT OF "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE WAS DETERMINED TO MEET DEVICE SPECIFICATIONS. ANALYSIS EVENT #1 WAS A SINGLE ANALYSIS EVENT, CONSISTING OF 2 SEGMENTS. SEGMENTS 1 & 2 WERE BOTH FOUND TO HAVE NO KNOWN MATCHING PATTERN, SO A THIRD SEGMENT WAS NOT NECESSARY. IN THIS CASE THE WAVEFORM DID NOT RECORD ENOUGH MATCHING CONDITIONS TO BE DETERMINED SHOCKABLE IN EITHER OF THE FIRST 2 ANALYSIS SEGMENTS. IT SHOULD ALSO BE NOTED THAT THERE WAS CPR DETECTED DURING THE FIRST SEGMENT OF THE WAVEFORM ANALYSIS. THE PRESENCE OF CPR OR OTHER PHYSICAL INTERFERENCE WITH THE PATIENT CAN RESULT IN SIGNIFICANT INTERFERENCE AND ARTIFACT IN THE PRESENTING WAVEFORM. THIS CAN SIGNIFICANTLY IMPACT THE RECORDED WAVEFORM METRICS AND, IN MANY CASES, INFLUENCE THE ANALYSIS DECISION. 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

    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 27-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS, DISPLAYED A "CABLE FAULT" MESSAGE, AND "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. 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
    903996 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 620-2321011-26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Death