BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 20836096 · Received December 3, 2024

    Report

    Report Number
    1220908-2024-04353
    Event Type
    Death
    Date Received
    December 3, 2024
    Date of Event
    November 10, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946029524
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT OBSERVED DURING THE EVALUATION. THE DEVICE PERFORMED TO SPECIFICATION. A REVIEW OF THE DEVICE LOG INDICATES THE CUSTOMER WAS NOT IN THE CORRECT LEAD VIEW. THE DEVICE WAS SWITCHED FROM PAD VIEW TO LEAD VIEW MODE WITH NO ECG CABLE CONNECTED TO THE PATIENT. ONCE ECG LEADS WERE ATTACHED TO THE DEVICE, A CLEAR ECG SIGNAL WAS OBTAINED THROUGH LEAD I VIEW. THE DEVICE WAS RETURNED WITH AN MFC CABLE AND CPR D ADAPTER AND PASSED FULL FUNCTIONAL TESTING WITH THE RETURNED ACCESSORY. 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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED 4-LEADS AND ANOTHER DEVICE FOR RHYTHM ANALYSIS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414310 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 630-2221111-01 NA 00847946029524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death