BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 11864538 · Received May 21, 2021

    Report

    Report Number
    8030229-2021-00290
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    August 18, 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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN THEY ADMITTED A PATIENT ONTO A CENTRAL NURSE'S STATION (CNS) TILE / BEDSIDE MONITOR, AND THE PATIENT IS ADMITTED TO THEIR CORRECT TILE / DEVICE. THEN IN ANOTHER PATIENT TILE, IT REMOVES AN EXISTING PATIENT NAME AND DUPLICATES THE PATIENT NAME WITH THE ONE THAT WAS JUST ADMITTED. THE VITALS ON THE OTHER TILE ARE FOR THE OTHER PATIENT BUT IT IS LISTED UNDER THE INCORRECT NAME. THIS SAME PATIENT NAME ALSO SHOWED UP ON THE BEDSIDE MONITOR AS WELL. THIS ISSUE OCCURRED AT AROUND 7AM WHEN THE PATIENT WAS ADMITTED. NO PATIENT HARM 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. ADDITIONAL INFORMATION: PRODUCT CODE FOR THE CENTRAL MONITOR SYSTEM HAS ALWAYS BEEN MHX.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN ADMITTING A PATIENT TO THE CENTRAL NURSE'S STATION (CNS), A PREVIOUSLY ADMITTED PATIENT'S ID WAS OVERRIDDEN BY THE NEW PATIENT'S INFORMATION. THE OTHER PATIENT'S TILE WAS SHOWING THAT PATIENT'S VITALS, BUT IT WAS LISTED UNDER THE INCORRECT NAME. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE ISSUE COULD NOT BE INVESTIGATED DUE TO THE CUSTOMER NOT HAVING PROVIDED THE NECESSARY DEVICE LOGS. AS SUCH, A ROOT CAUSE COULD NOT BE IDENTIFIED. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. A COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. T. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS. BEDSIDE MONITOR MODEL: CSM-1901A SN: (B)(6). BEDSIDE MONITOR MODEL: CSM-1901A SN: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN THEY ADMITTED A PATIENT ONTO A CENTRAL NURSE'S STATION (CNS) TILE / BEDSIDE MONITOR, AND THE PATIENT IS ADMITTED TO THEIR CORRECT TILE / DEVICE. THEN IN ANOTHER PATIENT TILE, IT REMOVES AN EXISTING PATIENT NAME AND DUPLICATES THE PATIENT NAME WITH THE ONE THAT WAS JUST ADMITTED. THE VITALS ON THE OTHER TILE ARE FOR THE OTHER PATIENT BUT IT IS LISTED UNDER THE INCORRECT NAME. THIS SAME PATIENT NAME ALSO SHOWED UP ON THE BEDSIDE MONITOR AS WELL. THIS ISSUE OCCURRED AT AROUND 7AM WHEN THE PATIENT WAS ADMITTED. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN ADMITTING A PATIENT TO THE CENTRAL NURSE'S STATION (CNS), A PREVIOUSLY ADMITTED PATIENT'S ID WAS OVERRIDDEN BY THE NEW PATIENT'S INFORMATION. THE OTHER PATIENT'S TILE WAS SHOWING THAT PATIENT'S VITALS, BUT IT WAS LISTED UNDER THE INCORRECT NAME. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760253 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CSM-1901A SN (B)(6).| CSM-1901A SN (B)(6).| CSM-1901A SN (B)(6).| CSM-1901A SN (B)(6).