BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11319456 · Received February 11, 2021

    Report

    Report Number
    8030229-2021-00071
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 12, 2021
    Report Date
    May 4, 2021
    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
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON 01/12/2021, THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD AN HDD PORT 1 AND HDD PORT2 ERROR FLASHING ON THE DISPLAY SCREEN WHILE MONITORING PATIENTS. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK SCORE IS LOW. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. NK TECH SUPPORT STATED THAT THIS ISSUE WAS A RESULT OF THE HDD'S OPERATING FOR MORE THAN 20,000 HOURS. NK TS WALKED THE CUSTOMER THROUGH HOW TO REMOVE THESE ERROR MESSAGES PER TN-1270. AS THIS ISSUE IS NOT A RESULT OF A DEFICIENCY OR NON-CONFORMANCE OF AN NK DEVICE, A ROOT CAUSE ANALYSIS AND CAPA ARE NOT REQUIRED. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. ATTEMPT # 1: 02/11/2021 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL THE INFORMATION : NO REPLY WAS RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OF HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON CENTRAL NURSING STATION (CNS), THEY SAW HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON THE CENTRAL NURSING STATION(CNS) AND THERE WAS NO OTHER ISSUES WITH THE CENTRAL NURSE'S STATION (CNS) ONLY THAT THESE ERRORS WERE DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) SOFTWARE. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED OF HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON CENTRAL NURSING STATION (CNS). THEY SAW HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON THE CENTRAL NURSING STATION(CNS) AND THERE WAS NO OTHER ISSUES WITH THE CENTRAL NURSE'S STATION (CNS) ONLY THAT THESE ERRORS WERE DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) SOFTWARE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OF HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON CENTRAL NURSING STATION (CNS), THEY SAW HARD DRIVE (HDD) PORT 1 AND HARD DRIVE (HDD) PORT2 ERROR FLASHING ON THE CENTRAL NURSING STATION(CNS) AND THERE WAS NO OTHER ISSUES WITH THE CENTRAL NURSE'S STATION (CNS) ONLY THAT THESE ERRORS WERE DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) SOFTWARE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215813 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NI.| NI.