BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4143663 · Received August 12, 2014

    Report

    Report Number
    8030229-2014-00041
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER PERFORMING A HARD SHUTDOWN TO GET THE SYSTEM BACK UP AND RUNNING, FURTHER TROUBLESHOOTING SHOWED THAT THE HARD DRIVE 1 WAS TRYING TO REBUILD. OUR TECH SUPPORT GUIDED THE CUSTOMER THROUGH REMOVING HARD DRIVE 1 AND VERIFIED THE SYSTEM RAN AS NORMAL. FOLLOWED UP WITH THE CUSTOMER IN THE MORNING AND THEY HAVE NOT HAD FURTHER ISSUES. SENDING IN A REPLACEMENT HARD DRIVE AND RETURN OF DEFECTIVE REQUESTED FOR FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. DEVICE EVALUATED BY MANUFACTURER. MANUFACTURER NARRATIVE: THE CENTRAL MONITORING SYSTEM (CNS)DISPLAY IS FROZEN AND HAS DONE THIS SEVERAL TIMES TODAY. AFTER PERFORMING A HARD SHUTDOWN TO GET THE SYSTEM BACK UP AND RUNNING, FURTHER TROUBLESHOOTING SHOWED THAT THE HARD DRIVE 1 WAS TRYING TO REBUILD. OUR TECH SUPPORT GUIDED THE CUSTOMER THROUGH REMOVING HARD DRIVE 1 AND VERIFIED THE SYSTEM RAN AS NORMAL. FOLLOWED UP WITH THE CUSTOMER IN THE MORNING AND THEY HAVE NOT HAD FURTHER ISSUES. THE CUSTOMER WAS SENT A REPLACEMENT HARD DRIVE TO RESOLVE THE ISSUE. THE UNIT WAS EVALUATED AND THE REPORTED PROBLEM WAS DUPLICATED. THE HARD DISK DRIVE WAS DEGRADED. 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
    480004 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1