BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12186014 · Received July 16, 2021

    Report

    Report Number
    8030229-2021-00421
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 18, 2021
    Report Date
    February 23, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING COMM LOSS VIA A "NO SYNC" ERROR MESSAGE. THE CUSTOMER STATED A RECENT STORM CAUSED THE LIGHTS TO FLICKER. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) PERFORMED TROUBLESHOOTING STEPS. NK TS ADVISED THE CUSTOMER TO CHECK THE LED INDICATOR ON THE CNS, AND NO LIGHTS WERE ON. THE CUSTOMER COULD NOT PERFORM SOME OF THE TROUBLESHOOTING STEPS. NK TS ADVISED THE CUSTOMER TO CHECK THE CABLES FOR LOOSE CONNECTIONS. A FOLLOW-UP CALL FROM THE CUSTOMER STATED THAT THEIR IT DEPARTMENT REBOOTED THE CNS, WHICH RESOLVED THE ISSUE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. THE STORM MOST LIKELY CAUSED AN UNGRACEFUL EXIT OF THE CNS. A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS NO RECURRENCE OF A "NO SYNC" COMM LOSS MESSAGE.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT THERE WAS A STORM, AND LIGHTS WERE FLICKERING. THEN BOTH OF HER CENTRAL NURSE'S STATION (CNS) DISPLAYS SHOW NO SYNC AROUND 2 AM CDT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) HAD HER CHECK THE LED INDICATOR ON THE CNS. NONE ARE LIT. THE CNS IS PLUGGED INTO UPS, AND THE UPS LEFT BATTERY LED INDICATOR IS FULL AND RIGHT BATTERY LED INDICATOR HAS ONE BAR. TECH SUPPORT HAD HER REMOVE CNS POWER PLUG FROM UPS, PLUG IT INTO WALL OUTLET, AND POWER ON THE CNS. THE CNS POWERS ON, BUT SHE GETS "SCANNING AND REPAIRING DRIVE 36% COMPLETE. THEN, THE DISPLAYS GO BLACK AND SHOWS NO SYNC. TECH SUPPORT HAD HER POWER OFF THE CNS, RE-SEAT DISPLAY CABLES BEHIND CNS (DID NOT DO ACTUAL DISPLAYS SINCE THEY WERE HARD TO REACH), AND POWER ON CNS, BUT SHE STILL GETS NO SYNC ON BOTH DISPLAYS. THE NURSE WAS NOT COMFORTABLE DOING FURTHER TROUBLESHOOTING AND STATED THEY WOULD CONTACT A BIOMEDICAL ENGINEER (BME). TECH SUPPORT CALLED THE CUSTOMER BACK, AND THEY STATED THEY CALLED THEIR IT. THEY REBOOTED THE CNS, AND THEN IT CAME BACK UP. THEY STATED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT THAT THERE WAS A STORM, AND LIGHTS WERE FLICKERING. THEN BOTH OF HER CENTRAL NURSE'S STATION (CNS) DISPLAYS SHOW NO SYNC AROUND 2 AM CDT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) HAD HER CHECK THE LED INDICATOR ON THE CNS. NONE ARE LIT. THE CNS IS PLUGGED INTO UPS, AND THE UPS LEFT BATTERY LED INDICATOR IS FULL AND RIGHT BATTERY LED INDICATOR HAS ONE BAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081856 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown