BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 5543024 · Received April 1, 2016

    Report

    Report Number
    8030229-2016-00138
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL MONITORING SYSTEM) IS GETTING A SSD ACCESS ERROR. THE CUSTOMER SENT THE LOG FILES TO NIHON KOHDEN TECHNICAL SUPPORT FOR ANALYSIS. A LOANER UNIT WAS SENT OUT TO THE CUSTOMER WHILE THIS REPORT IS UNDER INVESTIGATION. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED A SSD ACCESS ERROR. THE CUSTOMER SENT THE LOG FILES AND THE DEVICE TO NIHON KOHDEN FOR ANALYSIS, EVALUATION, AND REPAIR. THE SSD ACCESS ERROR COULD NOT BE DUPLICATED. WHEN BOOTING UP, THE DEVICE DISPLAYED A "CNS6201.EXE- CORRUPT FILE" ERROR MESSAGE, INDICATING THAT THE FILE OR DIRECTORY C:\$MFT WAS CORRUPT AND UNREADABLE. RUNNING A SCAN DISK RESOLVED THE ISSUE AND THE CNS STARTED TO FUNCTION NORMALLY. NIHON KOHDEN'S REPAIR CENTER COMPLETED ALL OF THE STEPS IN THE MAINTENANCE CHECK SHEET OF THE SERVICE MANUAL AND PERFORMED AN EXTENDED TEST. THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL MONITORING SYSTEM) IS GETTING A SSD ACCESS ERROR. THE CUSTOMER SENT THE LOG FILES TO NIHON KOHDEN TECHNICAL SUPPORT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197190 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN TOMIOKA CORPORATION CNS-6201A

    Patients

    Seq Age Sex Outcome Treatment
    1