BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700A

    MDR report key: 7168898 · Received January 5, 2018

    Report

    Report Number
    8030229-2018-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 7, 2017
    Report Date
    July 8, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921000663
    PMA / PMN Number
    K023475
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: DETAILS OF THE COMPLAINT: ON (B)(6) 2017, BME (B)(6) AT (B)(6) REPORTED THE CNS (MU-971RA SN: (B)(4)) HDD FAILED AND THE CNS BOOTS UP TO THE BSOD (BLUE SCREEN OF DEATH). CUSTOMER SAID THIS WAS A SPARE CNS. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE IN ORDERING A NEW HDD. SERVICE PERFORMED: SEND OUT CONFIGURED HARD DRIVE WITH CNS VER 01-87. HDD S/N (B)(4). INVESTIGATION RESULT: THE DEVICE WAS PUT INTO SERVICE ON 07/21/2010, WHICH IS OVER 7 YEARS PRIOR TO THE REPORTED ISSUE. THERE WAS A FAILURE OF THE CNS'S HDD. PERFORMANCE AND DEGRADATION OF THE HDD IS AFFECTED BY SEVERAL FACTORS SUCH AS STORAGE, HANDLING, USE, AND POWER CONDITIONS. AS THE DEVICE IS OPERATED AT THE CUSTOMER'S FACILITY, IT IS THE CUSTOMER'S RESPONSIBILITY TO ENSURE PROPER ENVIRONMENT AND MAINTENANCE FOR THE UNIT. NO NKA EVALUATION WAS PERFORMED AS THE CNS/HDD WAS NOT RETURNED. PER CNS-9701A SERVICE MANUAL REVISION E, THE HARD DISK'S EXPECTED LIFESPAN IS EVERY 2 YEARS AND CUSTOMER IS RECOMMENDED TO PERIODICALLY REPLACE THE COMPONENT. INFORMATION OF WHETHER THIS WAS REGULARLY PERFORMED BY THE CUSTOMER IS NOT AVAILABLE. A REVIEW OF DEVICE HISTORY SHOWS NO TICKETS OPENED FOR HDD ISSUES OR REPLACEMENT FOR THIS UNIT IN ITS 7 YEARS OF SERVICE. ISSUES WITH THE HDD COULD BE DETECTED DURING THE PERFORMANCE OF REGULAR MAINTENANCE INSPECTIONS EVERY 6 MONTHS, AS RECOMMENDED IN THE CNS-9701A SERVICE MANUAL. NK SUPPORT ASSISTED CUSTOMER BY SENDING A NEW CONFIGURED HDD AND CUSTOMER WAS TO PERFORM REPLACEMENT OF THE HDD INTERNALLY. PROCEDURE FOR REPLACEMENT OF THE HDD IS OUTLINED IN THE SERVICE MANUAL UNDER "HARD DISK REPLACEMENT FLOW" IN TROUBLESHOOTING SECTION AND "REPLACING THE HARD DISK" IN DISASSEMBLY AND ASSEMBLY SECTION. THERE WERE NO FURTHER REPORTED ISSUES WITH THE CNS'S HDD. THE UNIT WAS IN USE WITH A PATIENT AND THERE WAS NO REPORTED PATIENT HARM. BASED ON THE GIVEN INFORMATION, THIS ISSUE IS NOT SUSPECTED TO BE CAUSED BY DEFICIENT DESIGN. CORRECTION: APPROXIMATE AGE OF DEVICE: INCORRECTLY CALCULATED. DATE RECEIVED BY MANUFACTURER: SHOULD BE 12/07/2017 NOT 01/05/2018 AS LISTED ON MDR INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE HDD FAILED AND BOOTED UP TO THE BLUE SCREEN OF DEATH.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE HDD FAILED AND BOOTED UP TO THE BLUE SCREEN OF DEATH. THE UNIT WAS ON PATIENT USE, HOWEVER NO REPORT OF PATIENT HARM WAS MADE. NIHON KOHDEN TECHNICAL SUPPORT PROVIDED THE PART NUMBER FOR A NEW HDD TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HDD FAILED AND BOOTED UP TO THE BLUE SCREEN OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11627 CNS-9700A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700A N/A 04931921000663

    Patients

    Seq Age Sex Outcome Treatment
    1