BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9594231 · Received January 15, 2020

    Report

    Report Number
    8030229-2020-00034
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 26, 2019
    Report Date
    July 8, 2021
    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
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: DETAILS OF COMPLAINT: ON (B)(6) 2019, THE CUSTOMER AT (B)(6) HOSPITAL & CLINIC, INC REPORTED THAT THE CENTRAL NURSE'S STATION (CNS: (B)(4); SN-(B)(6) BLUE SCREENED WHILE MONITORING PATIENTS. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. SERVICE PERFORMED: ON INVESTIGATION, IT WAS FOUND THAT THE DISPLAY WAS CONNECTED TO A KVM, WHICH WAS DEGRADED AND NEEDED REPLACEMENT. INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A DEGRADED KVM, WHICH IS AN ANCILLARY DEVICE. THE OVERALL RISK OF THIS EVENT IS "MEDIUM." THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS SINCE THE ISSUE WAS CAUSED DUE TO A USER FACILITY MAINTAINED ANCILLARY DEVICE MALFUNCTION. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: B2. B6. B7. D4 LOT # & EXPIRATION DATE. D6A & D6B. D7B. F1 - F14. G4 DEVICE BLA NUMBER. G5. G7. H7. H9. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6. D10. ATTEMPT # 1: (B)(6) 2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. 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 ONE OF THE DUAL SCREENS FOR THE CENTRAL NURSE'S STATION (CNS) BLUE SCREENED. THEY HAVE STATED THAT THE DEVICE HAS A KVM (KERNEL-BASED VIRTUAL MACHINE) AND THAT THEY WILL CHECK THE STATUS OF THAT AND REQUESTED THE PART NUMBER FOR THAT AS WELL. IT IS UNCLEAR WHETHER THE MONITORS WERE SET UP TO MIRROR EACH OTHER OR WHETHER THEY DISPLAYED DIFFERENT DEVICES ON EACH MONITOR. WE HAVE REQUESTED CLARIFICATION REGARDING THIS MATTER FROM THE CUSTOMER BUT HAVE NOT RECEIVED A RESPONSE BACK YET. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ONE OF THE DUAL SCREENS FOR THE CENTRAL NURSE'S STATION (CNS) BLUE SCREENED. THEY HAVE STATED THAT THE DEVICE HAS A KVM (KERNEL-BASED VIRTUAL MACHINE) AND THAT THEY WILL CHECK THE STATUS OF THAT AND REQUESTED THE PART NUMBER FOR THAT AS WELL. IT IS UNCLEAR WHETHER THE MONITORS WERE SET UP TO MIRROR EACH OTHER OR WHETHER THEY DISPLAYED DIFFERENT DEVICES ON EACH MONITOR. WE HAVE REQUESTED CLARIFICATION REGARDING THIS MATTER FROM THE CUSTOMER BUT HAVE NOT RECEIVED A RESPONSE BACK YET. IF THE MONITORS MIRRORED EACH OTHER, THIS WOULD NOT BE REPORTABLE. HOWEVER, IF THE MONITORS WERE DISPLAYING DIFFERENT DEVICES ON EACH MONITOR, AND IF THE REPORTED MALFUNCTION WERE TO OCCUR THIS WOULD BE A REPORTABLE EVENT. THEREFORE, WE ARE FILING A REPORT TO ERR ON THE SIDE OF CAUTION. 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. 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 THE ONE OF THE DUAL SCREENS FOR THE CENTRAL NURSE'S STATION (CNS) BLUE SCREENED. THEY HAVE STATED THAT THE DEVICE HAS A KVM (KERNEL-BASED VIRTUAL MACHINE) AND THAT THEY WILL CHECK THE STATUS OF THAT AND REQUESTED THE PART NUMBER FOR THAT AS WELL. IT IS UNCLEAR WHETHER THE MONITORS WERE SET UP TO MIRROR EACH OTHER OR WHETHER THEY DISPLAYED DIFFERENT DEVICES ON EACH MONITOR. WE HAVE REQUESTED CLARIFICATION REGARDING THIS MATTER FROM THE CUSTOMER BUT HAVE NOT RECEIVED A RESPONSE BACK YET. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54386 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1