BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 19549644 · Received June 17, 2024

    Report

    Report Number
    1220908-2024-02302
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    February 6, 2024
    Report Date
    June 5, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS D1 UPDATED, D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED (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). EVALUATION RESULTS: THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE CUSTOMER HAS RESPONDED AND INDICATED THE PRODUCT WILL NOT BE RETURNING TO ZOLL.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE AND INTERNAL HANDLES WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE FUNCTIONAL TESTING INCLUDING IMPEDANCE CALIBRATION TESTING, DEFIB/PACER STRESS TESTING, BENCH HANDLING, AND DEFIB CYCLING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE ACTIVITY LOGS WERE NOT AVAILABLE FOR REVIEW AS THEY HAD BEEN OVERWRITTEN BY USE OF THE DEVICE AFTER THE EVENT. NO CLINICAL LOG FILES WERE AVAILABLE FOR REVIEW. 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 CLINICIAN WAS NOT SATISFIED WITH THE CLINICAL EFFECTIVENESS OF THE DEVICE. THE DEVICE WOULD TAKE MULTIPLE DEFIBRILLATIONS TO CONVERT A PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT ALSO INDICATED THAT THE PATIENT WAS CONNECTED TO A HEART-LUNG MACHINE DURING THE EVENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2024-02310, 1220908-2024-02329, AND 1220908-2024-02330 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009872 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001000001110222 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown