BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 12405447 · Received September 1, 2021

    Report

    Report Number
    8030229-2021-01553
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 1, 2021
    Report Date
    May 15, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ON 08/01/2021, SOME OF THE BEDSIDE MONITORS (BSMS) THAT WERE MONITORED AT THE CENTRAL NURSE'S STATION (CNS) WERE DISAPPEARING FROM THE SECTOR. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: AN NKC INVESTIGATION OPENED FOR ANOTHER TICKET, 124222, WHICH IS FOR THE SAME DEVICE, FOUND THAT THE ISSUE OF TILES DISAPPEARING WAS OCCURRING DUE TO THE SOFTWARE HAVING BEEN CORRUPTED. A SERIAL NUMBER REVIEW OF (B)(6) SN:(B)(6) REVEALED THAT THE CUSTOMER PREVIOUSLY REQUESTED BLANK HDDS IN WHICH THEY WOULD MIRROR WITH THE EXISTING HDDS. THOSE OLDER HDDS WERE INVOLVED IN A POWER LOSS EVENT WHICH LIKELY CAUSED SOFTWARE CORRUPTION IN ONE OTHER TICKET 102284. AS A RESULT, THE HDDS FOR SN:(B)(6) WERE MIRRORED WITH CORRUPTED SOFTWARE, LEADING TO MISSING TILES. THE ROOT CAUSE OF THE MISSING TILES IS SOFTWARE CORRUPTION DUE TO POWER LOSS. THE NKC INVESTIGATION LISTS POTENTIAL HAZARDS, CAUSES, ACTION TAKEN, AND RESIDUAL RISKS FOR THE CNS. ALL RISKS ARE ACCEPTABLE. BASED ON THE RISK ASSESSMENT ABOVE, THIS TYPE OF FAILURE MODE IS UNLIKELY TO RESULT IN PATIENT HARM.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE HAVING ISSUES WITH THIS CENTRAL NURSE'S STATION (CNS). HE STATED THAT SOME BEDSIDES THAT THE CNS WAS MONITORING WILL DISAPPEAR FROM THE SECTOR. HE STATED THAT AN INCIDENT OCCURRED ON (B)(6) 2021 WHERE A BEDSIDE DISAPPEARED, AND THE ON CALL BIOMED HAD TO BE CALLED IN TO RE-MONITOR THAT BEDSIDE. THEY STATED THAT THIS ISSUE OCCURS OFTEN AND THAT IT IS ALSO HAPPENING ON TWO OTHER CNSS. HE DID NOT HAVE THE INFORMATION OF THE TWO OTHER CNSS BUT WILL PROVIDE THAT AS SOON AS THEY CAN. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) EXPLAINED TO THEM THAT THEY CAN TRY TO REBOOT THE CNSS BY EXITING THE APPLICATION AND RESTARTING FROM WINDOWS. THEY STATED THEY WOULD GIVE THAT A TRY. TECH SUPPORT INFORMED THEM THAT IF ISSUE KEEPS OCCURRING LOGS WILL NEED TO BE SENT IN TO PROPERLY INVESTIGATE THIS ISSUE. THE CUSTOMER LATER STATED THAT REBOOTING THE CNSS SEEMS TO HAVE RESOLVED THE ISSUE FOR NOW, BUT THEY WILL CONTINUE TO MONITOR THIS ISSUE. THEY ALSO ASKED FOR NIHON KOHDEN RECOMMENDATIONS FOR REBOOTING THE CNSS. QA ADVISED THAT THE CNSS SHOULD BE RESTARTED EVERY 3 MONTHS. NO PATIENT HARM WAS REPORTED. 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ON 08/01/2021, SOME OF THE BEDSIDE MONITORS (BSMS) THAT WERE MONITORED AT THE CENTRAL NURSE'S STATION (CNS) WERE DISAPPEARING FROM THE SECTOR. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE HAVING ISSUES WITH THIS CENTRAL NURSE'S STATION (CNS). HE STATED THAT SOME BEDSIDES THAT THE CNS WAS MONITORING WILL DISAPPEAR FROM THE SECTOR. HE STATED THAT AN INCIDENT OCCURRED ON (B)(6) 2021 WHERE A BEDSIDE DISAPPEARED, AND THE ON CALL BIOMED HAD TO BE CALLED IN TO RE-MONITOR THAT BEDSIDE. THEY STATED THAT THIS ISSUE OCCURS OFTEN AND THAT IT IS ALSO HAPPENING ON TWO OTHER CNSS. HE DID NOT HAVE THE INFORMATION OF THE TWO OTHER CNSS BUT WILL PROVIDE THAT AS SOON AS THEY CAN. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) EXPLAINED TO THEM THAT THEY CAN TRY TO REBOOT THE CNSS BY EXITING THE APPLICATION AND RESTARTING FROM WINDOWS. THEY STATED THEY WOULD GIVE THAT A TRY. TECH SUPPORT INFORMED THEM THAT IF ISSUE KEEPS OCCURRING LOGS WILL NEED TO BE SENT IN TO PROPERLY INVESTIGATE THIS ISSUE. THE CUSTOMER LATER STATED THAT REBOOTING THE CNSS SEEMS TO HAVE RESOLVED THE ISSUE FOR NOW, BUT THEY WILL CONTINUE TO MONITOR THIS ISSUE. THEY ALSO ASKED FOR NIHON KOHDEN RECOMMENDATIONS FOR REBOOTING THE CNSS. QA ADVISED THAT THE CNSS SHOULD BE RESTARTED EVERY 3 MONTHS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307275 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown