BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 6013230 · Received October 9, 2016

    Report

    Report Number
    8030229-2016-00515
    Event Type
    Malfunction
    Date Received
    October 9, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE CNS (CENTRAL NURSE'S STATION) WILL NOT DISPLAY ANYTHING AND WILL NOT POWER ON. THE DEVICE WAS NEVER SENT IN FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL NURSE'S STATION) WILL NOT DISPLAY ANYTHING AND WILL NOT POWER ON. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL NURSE'S STATION) WILL NOT DISPLAY ANYTHING AND WILL NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664630 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A

    Patients

    Seq Age Sex Outcome Treatment
    1