BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 20833803 · Received December 3, 2024

    Report

    Report Number
    1220908-2024-04326
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017521
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. A REVIEW OF THE DEVICE LOG SHOWED THE DEVICE WAS ON DURING THE SCHEDULED READINESS TEST AT MIDNIGHT, SO THE DEVICE ATTEMPTED TO COMPLETE THE MISSED SELF-TEST DURING THE DEVICE'S NEXT POWER CYCLE. THE DEVICE FAILED THE READINESS TEST DUE TO THE DEVICE BEING CONFIGURED TO CPR/MWP/COMPLETE WHILE RECORDING THAT EXTERNAL PADDLES WERE CONNECTED. THERE IS NO EVIDENCE OF A SHOCK TO THE PATIENT ON THE REPORTED EVENT DATE. THE DEVICE APPEARS TO BE WORKING AS INTENDED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DID NOT RECOGNIZE A PATIENT WAS ATTACHED AND CHARGED TO PERFORM THE OVERNIGHT READINESS TEST. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337146 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001005201310012 NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown