BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 9177476 · Received October 10, 2019

    Report

    Report Number
    1220908-2019-03024
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DPS
    UDI-DI
    00847946014421
    PMA / PMN Number
    K011865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO CODE: MKJ. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4); THE REPORTED MALFUNCTION FOR DEVICE SHUT DOWN WAS DUPLICATED AND THE AC POWER CORD WAS REPLACED TO REMEDY THE PROBLEM. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE REPORTED MALFUNCTION FOR DEVICE DISPLAYED "POOR PAD CONTACT" WAS EVALUATED AND COMMUNICATION WITH THE CUSTOMER INDICATED THERE WERE NO ELECTRODE PADS ATTACHED AT THE TIME. THIS IS NORMAL OPERATION OF THE DEVICE IF THERE ARE NO PADS CONNECTED TO THE DEVICE. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970043 M SERIES DEFIBRILLATOR/PACEMAKER DPS ZOLL MEDICAL CORPORATION MSERIES CCT NA 00847946014421

    Patients

    Seq Age Sex Outcome Treatment
    1