BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 7321136 · Received March 7, 2018

    Report

    Report Number
    8030229-2018-00438
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    October 22, 2018
    Report Date
    October 24, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE ERRATIC GAS READINGS. SOME OF THE READINGS WERE AS LOW AS 1% AND HIGH AS 8% WHEN CALIBRATING THE GAS FOR 4%. THEN THERE WAS NO READING AT ALL. NO PATIENT HARM WAS REPORTED. THE CUSTOMER HAS SEND THE UNIT FOR EVALUATION. THE UNIT WAS CLEANED AND EVALUATED. THE REPORTED PROBLEM OF INACCURATE/NO READING COULD NOT BE DUPLICATED THROUGH TESTING, TROUBLESHOOTING AND EXTENDED OPERATION OF THE DEVICE. REVIEW OF THE DEVICE HISTORY INDICATES NO PREVIOUS CND STATUS. THE UNIT WAS TESTED PER OPERATOR'S/SERVICE MANUAL AND OPERATES TO MANUFACTURER'S SPECIFICATIONS. UNIT HAS BEEN SENT BACK TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2018, CUSTOMER REPORTED CNS DEVICE REBOOTED ON ITS OWN AT 8:00AM. CUSTOMER STATED THAT THERE SEEMS TO BE AN ON-GOING ISSUE WITH CNS EXHIBITING THE SAME SYMPTOMS PRIOR TO FIVE-YEAR WARRANTY EXPIRATION. ON 11/8/2018 NK TS WENT ON-SITE PER CUSTOMER REQUEST TO UPDATE SOFTWARE TO THE LATEST VERSIONS FOR 11 CNS DEVICES. THIS UPDATE WAS PERFORMED UNDER NOTIFICATION 300150221. THIS NOTIFICATION STATED THIS UPDATE IS PER CUSTOMER REQUEST, RATHER THAN AS A RESULT OF THE REPORTED ISSUE. CNS SN AND VERSIONS: 00950 03-40 01084 05-01 01245 05-01 01369 03-40 01375 05-01 01382 03-40 01384 03-40 01386 03-40 01387 05-01 01398 05-01 01647 03-40 FOR SERIAL NUMBER: (B)(6), SOFTWARE WAS UPGRADED FROM 03-40 TO 05-01. SERVICE REQUESTED: SOFTWARE UPDATE TO LATEST VERSION. SERVICE PERFORMED: SOFTWARE UPDATE TO LATEST VERSION. INVESTIGATION RESULT: PU-621RA S/N: (B)(6) WAS PUT INTO SERVICE ON 7/24/2016. WARRANTY EXPIRED 7/24/2018. SERVICE HISTORY SHOWS THE FOLLOWING. ONE INCIDENT WAS RELATED TO UNINTERRUPTED POWER SUPPLY. 11/08/2018 300150221 - SOFTWARE UPDATE 10/22/2018 300148360 - CURRENT NOTIFICATION 10/19/2018 300144939 - SAME REQUEST AS 300150221 08/27/2018 300137000 - NOT RELATED TO REBOOTING 05/22/2018 300126040 - NOT RELATED TO REBOOTING 10/24/2017 300101466 - POWER ISSUE DUE TO UPS 08/21/2017 300094817 - NOT RELATED TO REBOOTING 08/04/2017 300092544 - POWER ISSUE DUE TO UPS 06/08/2017 300086418 - NOT RELATED TO REBOOTING SERVICE HISTORY FOR PU-621RA (CNS) AT THIS FACILITY SHOWS THE FOLLOWING REBOOTING INCIDENTS: 3/8/2019 300162591 - THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 10/22/2018 300148360 - CURRENT NOTIFICATION 9/4/2018 300137924 - THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 7/10/2018 300131182 - REBOOTING WAS CAUSED BY CHANGING IP ADDRESS OUTSIDE OF THE CNS APPLICATION. 7/2/2018 300130531 - THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 5/2/2018 300123551 - THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 2/27/2018 300115736 - THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. PER INVESTIGATION UNDER NOTIFICATION 300162591, THREE INVESTIGATIONS INTO REBOOTING AT THIS FACILITY WERE CONDUCTED BY NKC, THE MANUFACTURER. IT WAS SUSPECTED THAT THE ISSUE WAS CAUSED BY FACILITY'S NETWORKING ISSUE, HOWEVER IT COULD NOT BE CONFIRMED. SERVICE HISTORY ABOVE SHOWS THE ISSUE HAS NOT RE-OCCURRED SINCE 3/9/2019. DUE TO NETWORK ENVIRONMENT INFORMATION NOT AVAILABLE, THE ROOT CAUSE OF THE REBOOTING ISSUES AT THIS PARTICULAR FACILITY COULD NOT BE DETERMINED. A REVIEW OF MANUFACTURER'S DEVICE HISTORY RECORD SHOWS NO NONCONFORMING REPORT, NO DEVIATION AND NO CORRECTIVE AND PREVENTATIVE ACTIONS ASSOCIATED WITH THIS DEVICE. CORRECTED INFORMATION: D10. DEVICE AVAILABLE FOR EVALUATION? ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT. F7. TYPE OF REPORT. F11. DATE REPORT SENT TO FDA. F13. DATE REPORT SENT TO MANUFACTURER. G4. DATE RECEIVED BY MANUFACTURER. G7. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE? ADDITIONAL INFORMATION. CORRECTION. DEVICE EVALUATION. H3. DEVICE EVALUATED BY MANUFACTURER? H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SPONTANEOUSLY REBOOTED.

    Additional Manufacturer Narrative · 1

    A NIHON KOHDEN EMPLOYEE WAS ON-SITE TO INITIALIZE THE CNS AND UPGRADE THE SOFTWARE TO THE LATEST VERSION, AS ADVISED BY (B)(6) TECHNICAL SUPPORT, WHICH RESOLVED THE ISSUE. NO HARM WAS REPORTED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SPONTANEOUSLY REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162645 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NOT APPLICABLE 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1