BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 17964449 · Received October 19, 2023

    Report

    Report Number
    1220908-2023-03968
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA FOR EVALUATION AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. A REVIEW OF DEVICE LOGS SHOWED THAT THE 30 JOULE MANUAL TEST PASSED WITH NO ISSUES. HOWEVER, THE CODE READINESS TEST DID NOT PASS DUE TO THE CONFIGURATION SETUP OF THE DEVICE. FOR THE AUTOMATIC READINESS TEST THE DEVICE SHOULD BE SET UP WITH ONESTEP CPR, MWP, OR COMPLETE PADZ CONNECTED. THE LOG CONFIRMED THE DEVICE WAS SET UP TO ONESTEP BASIC PADZ INSTEAD OF ONESTEP CPR, MWP OR COMPLETE PADS. REPORTS OF THIS NATURE ARE NOT CONSIDERED TO MEET OUR REQUIREMENTS FOR SUBMISSION OF A MEDWATCH REPORT DUE TO NO POTENTIAL FOR CLINICAL IMPACT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D1 UPDATED, D4 MODEL # UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI #: ADDED 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.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653115 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001005201310262 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown