BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 10406053 · Received August 14, 2020

    Report

    Report Number
    8030229-2020-00448
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    January 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHILE THE EMERGENCY DEPARTMENT (ED) PHYSICIAN WAS LOOKING AT THE CENTRAL NURSE'S STATION (CNS) THE PATIENT TILES HAD BEEN INADVERTENTLY MOVED AROUND. WHEN THAT PHYSICIAN LATER LOOKED AT THE CNS, IT WAS NOTED THAT THE PATIENT'S VITAL SIGNS AND RHYTHM HAD DRASTICALLY CHANGED. THE PHYSICIAN WENT TO TREAT THE PATIENT AND NOTED THAT THE PATIENT DATA ON THE BEDSIDE MONITOR (BSM) DID NOT MATCH THE DATA ON THE CNS. THAT IS WHEN THE STAFF REALIZED THE TILES ON THE CNS HAD BEEN MOVED AROUND. THEY WERE LOOKING AT A DIFFERENT PATIENT. THE ED DEPARTMENT CONSIDERED THIS A "NEAR MISS." NO PATIENT HARM OR INJURY WAS REPORTED. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO LOCK THE BED TILES ON THE CNS. THE CUSTOMER INDICATED THEY HAD CLOSE CALLS WHERE THE BED TILE WAS INADVERTENTLY MOVED, AND THE MONITORING CLINICIAN DID NOT REALIZE THEY WERE MONITORING THE INCORRECT PATIENT. BEING ABLE TO DRAG AND DROP BED TILES FREELY IS A FEATURE OF THE CNS. AT THE TIME OF REPORTING, DISABLING THIS FEATURE WAS NOT YET AVAILABLE. IN RESPONSE TO REQUESTS FROM CUSTOMER TO BE ABLE TO LOCK BED TILES, DISABLING DRAG AND DROP BED TILES WAS ADDED TO THE CNS AS OPTION STARTING IN CNS-6201 V05-18 AND CNS-6801 V02-18. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE ISSUE IS SOFTWARE LIMITATION. THE OPTION TO DISABLE DRAG AND DROP WAS ADDED TO LATER VERSIONS OF THE SOFTWARE TO ADDRESS THIS LIMITATION.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHILE THE PHYSICIAN WAS LOOKING AS THE CENTRAL NURSE'S STATION (CNS) THEY HAD INADVERTENTLY MOVED TILES. LATER THAT ED PHYSICIAN WAS LOOKING AT THE CNS AND NOTED THAT THE PATIENT VITAL SIGNS AND RHYTHM HAD DRASTICALLY CHANGED. THE ED PHYSICIAN WENT TO THE ROOM TO TREAT THE PATIENT AND NOTED THAT THE PATIENT DATA ON THE BEDSIDE MONITOR DID NOT MATCH THE DATA ON THE CNS. IT WAS THEN; THAT THE STAFF NOTED THAT THE TILES ON THE CNS HAD CHANGED SPACES. THEY WERE LOOKING AT ANOTHER PATIENT. THE ED DEPARTMENT CONSIDERED THIS A "NEAR MISS." NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHILE THE PHYSICIAN WAS LOOKING AS THE CENTRAL NURSE'S STATION (CNS) THEY HAD INADVERTENTLY MOVED TILES. LATER THAT ED PHYSICIAN WAS LOOKING AT THE CNS AND NOTED THAT THE PATIENT VITAL SIGNS AND RHYTHM HAD DRASTICALLY CHANGED. THE ED PHYSICIAN WENT TO THE ROOM TO TREAT THE PATIENT AND NOTED THAT THE PATIENT DATA ON THE BEDSIDE MONITOR DID NOT MATCH THE DATA ON THE CNS. IT WAS THEN; THAT THE STAFF NOTED THAT THE TILES ON THE CNS HAD CHANGED SPACES. THEY WERE LOOKING AT ANOTHER PATIENT. THE ED DEPARTMENT CONSIDERED THIS A "NEAR MISS." 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. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: LOT NUMBER & EXPIRATION DATE. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. SERIAL NUMBER. APPROXIMATE AGE OF DEVICE. DEVICE MANUFACTURE DATE. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHILE THE PHYSICIAN WAS LOOKING AS THE CENTRAL NURSE'S STATION (CNS) THEY HAD INADVERTENTLY MOVED TILES. LATER THAT ED PHYSICIAN WAS LOOKING AT THE CNS AND NOTED THAT THE PATIENT VITAL SIGNS AND RHYTHM HAD DRASTICALLY CHANGED. THE ED PHYSICIAN WENT TO THE ROOM TO TREAT THE PATIENT AND NOTED THAT THE PATIENT DATA ON THE BEDSIDE MONITOR DID NOT MATCH THE DATA ON THE CNS. IT WAS THEN; THAT THE STAFF NOTED THAT THE TILES ON THE CNS HAD CHANGED SPACES. THEY WERE LOOKING AT ANOTHER PATIENT. THE ED DEPARTMENT CONSIDERED THIS A "NEAR MISS." NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874957 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown