BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 19550004 · Received June 17, 2024

    Report

    Report Number
    1220908-2024-02310
    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

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

    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.

    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 1220908-2024-02302, 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
    2338037 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001000001110222 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown