BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4143675 · Received August 12, 2014

    Report

    Report Number
    8030229-2014-00035
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXCHANGED AND RETURN OF DEFECTIVE DEVICE REQUESTED FOR FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CENTRAL MONITORING SYSTEM (CNS)SCREEN CONTINUOUSLY FREEZES. THE CUSTOMER WAS SENT A REPLACEMENT HARD DISK DRIVE TO RESOLVE THE ISSUE. 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479698 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1