BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 5435992 · Received February 14, 2016

    Report

    Report Number
    8030229-2016-00059
    Event Type
    Malfunction
    Date Received
    February 14, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 14, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTS THAT THE CNS (CENTRAL MONITORING SYSTEM) BACKLIGHT IS OUT. THE CUSTOMER PLACED HIS CONSIGNMENT UNIT IN SERVICE AND PATIENTS ARE BEING MONITORED NORMALLY. THE CUSTOMER WAS PROVIDED WITH PART NUMBER A/E000528 AND TRANSFERRED TO CUSTOMER SERVICE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER REPORTS THAT THE CNS (CENTRAL MONITORING SYSTEM) BACKLIGHT IS OUT. THE CUSTOMER PLACED HIS CONSIGNMENT UNIT IN SERVICE AND PATIENTS ARE BEING MONITORED NORMALLY. THE CUSTOMER WAS PROVIDED WITH PART NUMBER A/E000528 AND TRANSFERRED TO CUSTOMER SERVICE. DUE TO THE AGE OF THIS COMPLAINT ADDITIONAL INFORMATION NECESSARY TO CONDUCT AN INVESTIGATION IS NOT READILY AVAILABLE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CNS (CENTRAL MONITORING SYSTEM) BACKLIGHT IS OUT. THE CUSTOMER PLACED HIS CONSIGNMENT UNIT IN SERVICE AND PATIENTS ARE BEING MONITORED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93174 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A

    Patients

    Seq Age Sex Outcome Treatment
    1