BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 8805570 · Received July 18, 2019

    Report

    Report Number
    8030229-2019-00306
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    September 26, 2019
    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
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER EXPERIENCED A HARD DRIVE FAILURE. IT WAS ALSO REPORTED THAT THE DISPLAYED WAS UNPLUGGED AND THEN PLUGGED INTO AN INCORRECT PORT. DETAILS SURROUNDING THE HARD DRIVE FAILURE AND THE TROUBLESHOOTING STEPS TAKEN ARE NOT AVAILABLE. CUSTOMER HAD NOT RESPONDED TO NK'S FOLLOW UP ATTEMPTS. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: DEVICE WAS PUT INTO SERVICE ON 4/23/2015. SERVICE HISTORY SHOWS THE FOLLOWING: 06/26/2019 300175184 - CURRENT NOTIFICATION 05/21/2019 300171196 - CUSTOMER REPORTED RAID VOLUME WAS DEGRADED FROM A FAILED HARD DRIVE. CUSTOMER FOLLOWED SERVICE MANUAL PROCEDURES IN REPLACED THE FAILED RAID HARD DRIVE, WHILE DEVICE CONTINUED TO RUN ON THE SECONDARY HARD DRIVE. 01/17/2017 300072516 - NOT RELATED TO HARD DRIVE 06/18/2015 300020110 - NOT RELATED TO HARD DRIVE BASED ON THE SERVICE HISTORY, THE CAUSE OF FAILED HARD DRIVE REPORTED ON 6/26/2019 COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE REPORTED SCREEN ISSUE WAS DUE TO DISPLAY CABLE WAS PLUGGED INTO THE WRONG PORT. D11. CONCOMITANT MEDICAL PRODUCTS: PRODUCTS USED WITH THE CENTRAL NURSES STATION WAS REQUESTED FROM THE CUSTOMER BUT THE INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE HARDRIVE FAILED AND NEEDED HELP WITH REPLACING IT. THIS DID NOT AFFECT PATIENT MONITORING. THEY REPORTED THE SCREEN WAS NOT WORKING AND TS FOUND THAT THEY HAD UNPLUGGED IT AND PLACED IT INTO THE CABLE INTO THE VGA PORT INSTEAD OF THE DVI PORT. ONCE THAT WAS CORRECTED THE ISSUES WERE RESOLVED. THE LATTER, UNPLUGGING THE DISPLAY DID AFFECT PATIENT MONITORING. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE HARDRIVE FAILED AND NEEDED HELP WITH REPLACING IT. THIS DID NOT AFFECT PATIENT MONITORING. THEY REPORTED THE SCREEN WAS NOT WORKING AND TS FOUND THAT THEY HAD UNPLUGGED IT AND PLACED IT INTO THE CABLE INTO THE VGA PORT INSTEAD OF THE DVI PORT. ONCE THAT WAS CORRECTED THE ISSUES WERE RESOLVED. THE LATTER, UNPLUGGING THE DISPLAY DID AFFECT PATIENT MONITORING. 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 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. CONCOMITANT MEDICAL DEVICES WERE REQUESTED FROM THE CUSTOMER BUT THE INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE HARDRIVE FAILED AND NEEDED HELP WITH REPLACING IT. THIS DID NOT AFFECT PATIENT MONITORING. THEY REPORTED THE SCREEN WAS NOT WORKING AND TS FOUND THAT THEY HAD UNPLUGGED IT AND PLACED IT INTO THE CABLE INTO THE VGA PORT INSTEAD OF THE DVI PORT. ONCE THAT WAS CORRECTED THE ISSUES WERE RESOLVED. THE LATTER, UNPLUGGING THE DISPLAY DID AFFECT PATIENT MONITORING. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596078 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1