BEUDAMED
    FDA Adverse Event Death Summary report: N

    CNS-9700

    MDR report key: 4386899 · Received December 24, 2014

    Report

    Report Number
    2080783-2014-00191
    Event Type
    Death
    Date Received
    December 24, 2014
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT EXPIRED WHILE THE ALARMS HAD BEEN SHUT OFF ON THE CENTRAL MONITORING SYSTEM (CNS) DUE TO EXCESSIVE ALARM FATIGUE (EXCESSIVE FALSE ALARMS). THEY WOULD LIKE US TO IMMEDIATELY INTERVENE TO DETERMINE IF THE ISSUE IS PRODUCT RELATED. THEY FEEL THAT THE NURSES HAVE BEEN WELL TRAINED ON SKIN PREP AND LEAD PLACEMENT, ALARM MODIFICATION AND MONITORING SYSTEM SETTINGS. THEY FEEL THAT THERE IS A TRUE PROBLEM WITH THE SETTINGS OR THE EQUIPMENT ITSELF. REF MFR # 8030229-2014-00191.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850368 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP. CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death