BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 8803139 · Received July 18, 2019

    Report

    Report Number
    1220908-2019-01965
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4); THE CUSTOMER RECEIVED A REPLACEMENT FRONT PANEL MEMBRANE TO RESOLVE THE MALFUNCTION. OUR ANALYSIS OF DATA INDICATES FOR REPORTS OF THIS TYPE IS ATTRIBUTED TO HIGH CONTACT RESISTANCE WITHIN THE FRONT PANEL MEMBRANE AND THAT THE KEYS DO RESPOND HOWEVER THEY NEED TO BE PUSHED HARDER TO ACTIVATE. DUE TO THE FACT THAT THE DEVICE CAN STILL ADMINISTER THERAPY, REPORTS OF THIS NATURE DO NOT TYPICALLY MEET THE CRITERIA FOR REPORTABILITY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO PACE AND SELECT ENERGY LEVEL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597732 M SERIES DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1