BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9766904 · Received February 27, 2020

    Report

    Report Number
    8030229-2020-00133
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 15, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS SUPPOSED TO BE MONITORING PATIENT B ON BED ID GZ-179. NO PATIENT VITALS DISPLAYED AND THE CORRECT PATIENT ID FOR PATIENT B WAS DISPLAYED, BUT A DIFFERENT PATIENT'S NAME AND DEMOGRAPHICS WAS ALSO DISPLAYED. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: ONLY THE PATIENT'S NAME AND BED ID COULD BE SEEN. WHEN THEY PHYSICALLY LOOKED AT THE GZ-179 (GZ B), THE GZ TRANSMITTER HAD A DIFFERENT PATIENT NAME (PATIENT A), AND NOT PATIENT B. PATIENT A WAS ADMITTED ON GZ-133 (GZ A) BUT WAS SHOWING IN GZ B. THE EVENT LOG INVESTIGATION OF THE EVENT WAS INCONCLUSIVE. A REVIEW OF THE HISTORY OF THE TICKETS FROM THE CUSTOMER'S FACILITY FOUND TWO (2) OTHER EVENTS (86503 ON A DIFFERENT CNS, 86634 ON THE SAME CNS) WHERE THERE WERE NO VITALS BEING DISPLAYED ON THE CNS, HOWEVER, BOTH INSTANCES DID NOT HAVE THE ISSUE OF A DIFFERENT PATIENT BEING DISPLAYED ON THE GZ DEVICE. THE LOGS OF THE EVENT FOR 86503 WERE EVALUATED, BUT THE LOG INVESTIGATION WAS ALSO FOUND TO BE INCONCLUSIVE. IT WAS IDENTIFIED THAT THERE WERE NETWORK COMMUNICATION ISSUES OCCURRING, BUT THE CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. POSSIBLE CAUSES OF VITALS NOT DISPLAYING ON THE CNS ARE NETWORK COMMUNICATION ISSUES, INCORRECT DISPLAYED PARAMETER SETTINGS, AND THE INCORRECT DEVICE BEING MONITORED ON THE CNS. ISSUES WITH THE NETWORK MAY CAUSE COMMUNICATION ISSUES WITH THE TELEMETRY DEVICES AND THE CNS, THIS ISSUE WOULD BE ACCOMPANIED BY COMMUNICATION LOSS OR SIGNAL LOSS. HOWEVER, IN SITUATIONS WHERE THERE ARE DUPLICATE IP ADDRESSES ON THE NETWORK OR DUPLICATE BED NAMES THESE ERROR MESSAGES MAY NOT APPEAR AND MAY CAUSE CONFLICT IN COMMUNICATING BETWEEN DEVICES OF THE SAME IP AND SAME BED NAMES. IF THE DISPLAYED PARAMETER SETTINGS ARE SET INCORRECTLY, THE DESIRED PARAMETERS/VITALS MAY NOT BE DISPLAYED ON THE CNS AND MAY RESULT IN NOT SEEING ANY VITALS ON THE CNS TILE. IF THE INCORRECT DEVICE IS BEING MONITORED ON THE CNS TILE AND THE DEVICE BEING MONITORED IS NOT IT USE, NO VITALS WOULD BE DISPLAYED ON THE CNS TILE. THE USER MAY INADVERTENTLY MONITOR AN INCORRECT DEVICE, IF THE BED TILE IS LABELED INCORRECTLY, IF THERE IS AN INCORRECT PATIENT NAME ON THE TELEMETRY DEVICE, OR IF A PATIENT TRANSFER WAS PERFORMED. A POSSIBLE CAUSE OF THE INCORRECT PATIENT'S NAME ISSUE IS AN ERRONEOUS PATIENT TRANSFER, OR MISLABELED DEVICE. WITHOUT A DEFINITIVE ROOT CAUSE, ACTIONS TO PREVENT RECURRENCE OF THE ISSUE COULD NOT BE PERFORMED. SHOULD THE ISSUE RECUR, A MONITORING CLINICIAN WOULD BE ABLE TO EASILY DETECT THE ISSUE AS THERE ARE NO WAVEFORMS BEING DISPLAYED ON THE TILE. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D8 WAS THIS DEVICE SERVICED BY A THIRD PARTY? D10 CONCOMITANT MEDICAL DEVICE. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? 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) WAS SUPPOSED TO BE MONITORING PATIENT B ON BED ID (B)(4). NO PATIENT VITALS DISPLAYED AND THE CORRECT PATIENT ID FOR PATIENT B WAS DISPLAYED, BUT A DIFFERENT PATIENT'S NAME AND DEMOGRAPHICS WAS ALSO DISPLAYED. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS SUPPOSED TO BE MONITORING PATIENT B ON BED ID GZ-179. NO PATIENT VITALS DISPLAYED AND THE CORRECT PATIENT ID FOR PATIENT B WAS DISPLAYED, BUT A DIFFERENT PATIENT'S NAME AND DEMOGRAPHICS WAS ALSO DISPLAYED. 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 DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS. TRANSMITTER, MODEL: GZ-130PA, SN: (B)(4).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS SUPPOSED TO BE MONITORING PATIENT B ON BED ID GZ-179. NO PATIENT VITALS DISPLAYED AND THE CORRECT PATIENT ID FOR PATIENT B WAS DISPLAYED, BUT A DIFFERENT PATIENT'S NAME AND DEMOGRAPHICS WAS ALSO DISPLAYED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229898 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GZ-130PA SN (B)(6). | TRANSMITTER GZ-130PA SN (B)(6).