BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 5979944 · Received September 27, 2016

    Report

    Report Number
    1220908-2016-02313
    Event Type
    Death
    Date Received
    September 27, 2016
    Date of Event
    September 4, 2016
    Report Date
    September 7, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. IT IS IMPORTANT TO NOTE THAT THE ASSOCIATED ELECTRODES WERE NOT RETURNED TO ZOLL FOR EVALUATION AS PART OF THIS INVESTIGATION, HOWEVER, FOLLOW-UP COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE ELECTRODES WERE LEFT OUT OF THE PROTECTIVE PACKAGING FOR AN UNDISCLOSED AMOUNT OF TIME BEFORE THE REPORTED EVENT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIANS WERE PREPPING THE DEVICE FOR 25 MINUTES. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632665 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death