BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9977360 · Received April 20, 2020

    Report

    Report Number
    8030229-2020-00224
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 29, 2020
    Report Date
    June 25, 2020
    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
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INFORMATION: ON 03/29/2020, CUSTOMER AT (B)(6) SERVICES, INC. REPORTED THAT DEVICE HAD AN ERROR READING SOFTWARE REGISTRATION WAS INCOMPLETE ON PU-681RA WITH SERIAL#: (B)(6). INVESTIGATION SUMMARY: ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. HOWEVER, THE POSSIBLE CAUSES OF THE ISSUE INCLUDE EXCHANGING OF HARD DRIVES WITH THE SPARE UNIT, MULTIPLE ATTEMPTS OF HARD RESTART OF THE UNIT CAUSING SOFTWARE ISSUES, ETC. WARRANTY OF ISSUE IS VALID TILL 10/12/2020. IF THE CNS WERE MONITORING BEDSIDE MONITORS; THERE WOULD NOT BE A TOTAL LOSS OF MONITORING AS MONITORING AND ALARMS CONTINUE AT THE POINT OF CARE. NEIGHBORING BEDS ON THE CNS CAN BE MONITORED VIA INTERBED ON OTHER BEDSIDE MONITORS AND BEDS ON THE MALFUNCTIONING/REBOOTING/FREEZING CNS CAN BE MOVED TO OPEN TILES ON OTHER CNS'S. IF THE CNS WERE MONITORING TELEMETRY PATIENTS A TOTAL LOSS OF MONITORING WOULD OCCUR AND BASED ON THE DOWNTIME, THERE COULD BE A DELAY IN TREATMENT. POTENTIALLY CAUSING SERIOUS INJURY OR DEATH FOR TELEMETRY PATIENTS AND NO BEDSIDE PATIENTS. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP07-018, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM; AS THE SEVERITY OF THE ISSUE WILL BE MAJOR; HOWEVER, THE PROBABILITY OF THE REPORTED REGISTRATION ERROR IS LOW. ADDITIONAL DEVICE INFORMATION: D11 & C2: MULTIPLE BSM'S WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: BSM'S - MODEL: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) LOST SOFTWARE REGISTRATION WHILE MONITORING HARDWIRED BEDSIDE MONITOR'S.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) LOST SOFTWARE REGISTRATION WHILE MONITORING HARDWIRED BEDSIDE MONITOR'S. THE CUSTOMER ALSO REPORTED THAT BECAUSE OF THIS THEY ALREADY RESTARTED THE CNS MULTIPLE TIMES. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) PROVIDED THE CUSTOMER WITH THE NECESSARY REGISTRATION CODE, BUT THE CNS DISPLAYED "INCORRECT CODE" ERROR MESSAGE EACH TIME THEY ATTEMPTED TO USE IT. EVENTUALLY NK TS ADVISED THE CUSTOMER TO ENTER THE CODE AS ALL CAPS, WHICH INDEED RESOLVED THE ISSUE. 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. MULTIPLE BSM'S WERE USED IN CONJUNCTION WITH THE CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: BSM'S - MODEL: NI, S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) LOST SOFTWARE REGISTRATION WHILE MONITORING HARDWIRED BEDSIDE MONITOR'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440311 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 BEDSIDE MONITOR'S (BSM'S).| BEDSIDE MONITOR'S (BSM'S).