BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2082664 · Received May 3, 2011

    Report

    Report Number
    2082664
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PARAMEDICS ARRIVED ON THE SCENE, THE PATIENT WAS RECEIVING CARDIOPULMONARY RESUSCITATION (CPR) BY A BYSTANDER AND WAS IN PULSE LESS ELECTRICAL ACTIVITY (PEA). PATIENT WAS RESUSCITATED AFTER ONE ROUND OF MEDS (BICARB AND EPI) INTO A TACHYCARDIC RHYTHM. WHEN THE PARAMEDIC ATTEMPTED TO PRINT THE SUMMARY REPORT FROM THE M-SERIES MONITOR, THE PRINT OUT ONLY DISPLAYED THE PROPER START TIME AND END TIME AND A SIX-SECOND STRIP OF THE CPR. NO OTHER ECG FINDINGS WERE RECORDED, AVAILABLE. THIS DID NOT IMPEDE THE PATIENT'S CARE. THE MONITOR WAS PULLED FROM SERVICE AND BROUGHT TO BIOMEDICAL ENGINEERING FOR FURTHER TESTING. BIOMED COULD NOT CONFIRM REPORTED PROBLEM OF THE SUMMARY REPORT NOT PRINTING OUT. TESTING OF THE DEVICE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. RAN NUMEROUS SCENARIOS WITH PATIENT SIMULATOR AND EACH PRINTED A COMPLETE SUMMARY. THE DEVICE PASSED ALL FUNCTIONAL TESTS AND IS RECERTIFIED TO BE USED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR, EXTERNAL MKJ ZOLL MEDICAL CORPORATION M SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR