BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 12931492 · Received December 5, 2021

    Report

    Report Number
    8030229-2021-02055
    Event Type
    Malfunction
    Date Received
    December 5, 2021
    Date of Event
    November 5, 2021
    Report Date
    March 30, 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 REPORTED THAT THE TILES ON THE CENTRAL NURSE'S STATION (CNS) BECAME GREYED OUT AND THE CNS STOPPED MONITORING THE TILES. THEY CORRECTED THIS PROBLEM BY GOING TO THE MONITORING SCREEN AND RE-ADDING THE TILES TO THE CNS. AT FIRST THIS WAS HAPPENING ON TWO CNSS, ONE IN ICU AND ONE IN ED. THEY SWAPPED OUT ONE OF THE TWO WITH A SPARE CNS UNIT, BUT NOW THE SPARE UNIT WAS SHOWING THESE SYMPTOMS AS WELL. THEY REBOOTED THE CNSS, BUT THE ISSUE PERSISTS. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: REAL-TIME MONITORING REMAINS INTACT ON THE BEDSIDE MONITORS AND CAN STILL ALERT CAREGIVERS TO CHANGES IN VITAL SIGNS OR HEART RHYTHM. THIS ISSUE SHOULD BE EASILY NOTICEABLE, ALLOWING CAREGIVERS TO FIND ALTERNATE METHODS OF PATIENT MONITORING. AN NKC INVESTIGATION FOUND THAT THE ISSUE OF TILES DISAPPEARING WAS OCCURRING DUE TO THE SOFTWARE HAVING BEEN CORRUPTED. A SERIAL NUMBER REVIEW OF PU-621RA SN:(B)(6) REVEALED THAT THE CUSTOMER PREVIOUS REQUESTED BLANK HDDS IN WHICH THEY WOULD MIRROR WITH EXISTING HDDS. THOSE OLDER HDDS WERE INVOLVED IN A POWER LOSS EVENT WHICH LIKELY CAUSED ISSUES WITH SOFTWARE CORRUPTION IN 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 ISSUE IS NOT CONFIRMED TO BE A RESULT OF A DEFICIENCY IN THE DESIGN OR MANUFACTURING ON THE NK DEVICE. THERE WAS NO MALFUNCTION OF AN NK DEVICE.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE TILES ON THE CENTRAL NURSE'S STATION (CNS) BECOME GREYED OUT, AND THE CNS STOPS MONITORING THE TILES. THEY CORRECT THIS PROBLEM BY GOING TO THE MONITORING SCREEN AND RE-ADDING THE TILE TO THE CNS. HE SAID THAT THIS CAN HAPPEN TO ANY TILE, AND THEY WILL DROP OFF, AND THE CNS STOPS MONITORING THEM. AT FIRST THIS WAS HAPPENING ON TWO CNSS, ONE IN ICU AND ONE IN ED. THEY SWAPPED OUT ONE OF THE TWO WITH A SPARE CNS UNIT, BUT NOW THE SPARE UNIT WAS SHOWING THE SYMPTOMS AS WELL. THEY REBOOTED THE CNSS BUT THE ISSUE PERSISTS. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS. CENTRAL NURSE'S STATION: MODEL: CNS-6201A, SN: (B)(4). BEDSIDE MONITOR: MODEL: BSM-6501A, SN: (B)(4). BEDSIDE MONITOR: MODEL: BSM-6701A, SN: (B)(4).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE TILES ON THE CENTRAL NURSE'S STATION (CNS) BECAME GREYED OUT AND THE CNS STOPPED MONITORING THE TILES. THEY CORRECTED THIS PROBLEM BY GOING TO THE MONITORING SCREEN AND RE-ADDING THE TILES TO THE CNS. AT FIRST THIS WAS HAPPENING ON TWO CNSS, ONE IN ICU AND ONE IN ED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE TILES ON THE CENTRAL NURSE'S STATION (CNS) BECOME GREYED OUT, AND THE CNS STOPS MONITORING THE TILES. THEY CORRECT THIS PROBLEM BY GOING TO THE MONITORING SCREEN AND RE-ADDING THE TILE TO THE CNS. HE SAID THAT THIS CAN HAPPEN TO ANY TILE, AND THEY WILL DROP OFF, AND THE CNS STOPS MONITORING THEM. AT FIRST THIS WAS HAPPENING ON TWO CNSS, ONE IN ICU AND ONE IN ED. THEY SWAPPED OUT ONE OF THE TWO WITH A SPARE CNS UNIT, BUT NOW THE SPARE UNIT WAS SHOWING THE SYMPTOMS AS WELL. THEY REBOOTED THE CNSS BUT THE ISSUE PERSISTS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829203 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BSM-6501A (B)(6).| BSM-6501A (B)(6).| BSM-6701A (B)(6).| BSM-6701A (B)(6).| CNS-6201A (B)(6).| CNS-6201A SN (B)(6).