BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700A

    MDR report key: 10112989 · Received June 2, 2020

    Report

    Report Number
    8030229-2020-00300
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 7, 2022
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921000663
    PMA / PMN Number
    K023475
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECEIVED A "WINDOWS SYSTEM ERROR. DISC BOOT FAILURE, ENTER SYSTEM DISK AND RE-BOOT" AND THEN THE UNIT WAS BOOTED INTO A BLACK SCREEN AND WOULD NOT LOAD THE SOFTWARE. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) DETERMINED THAT THE UNIT WAS NO LONGER READING THE HARD DISK DRIVE (HDD). THE UNIT WAS AT ITS END OF LIFE, AND THERE WERE NO REPLACEMENT HDDS. TS SUGGESTED THAT THEY BUY A NEW CNS. THE BIOMED STATED THERE WAS A TOTAL OF 3 OR 4 PATIENTS BEING MONITORED ON TELEMETRY TRANSMITTERS ON CHANNELS 1 THRU 8. THESE TWO CNSS ARE NOT THE PRIMARY CNSS WHICH MONITOR THESE TELEMETRY BEDS. THEY WERE BEING USED IN CONJUNCTION WITH THE PRIMARY CNS DEVICES, SO THERE WAS NO INTERRUPTION IN PATIENT MONITORING. THEY ALSO MENTIONED THAT THEY WERE ABLE TO GET THE UNIT RUNNING AGAIN AND IT WAS CURRENTLY IN USE. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THIS EVENT OCCURRED DURING PATIENT USE. IF THE REPORTED MALFUNCTION WERE TO RECUR AND THE DEVICE BECAME NONFUNCTIONAL WHILE MONITORING PATIENTS, DELAYED TREATMENT IS LIKELY TO OCCUR SHOULD THE CUSTOMER NOT BE ABLE TO RESPOND TO THE EVENT. HOWEVER, IN THIS CASE, THE CUSTOMER SENT COMMUNICATION THAT THE CNS IN QUESTION WAS USED IN CONJUNCTION WITH THEIR PRIMARY CNS, WHICH WAS CONTINUING TO MONITOR THE PATIENTS. BASED ON THE SET UP OF THE CUSTOMER'S PATIENT MONITORING DEVICES, THE RISK OF PATIENT HARM CAN BE MITIGATED AS FAILURE OF A CNS WILL NOT RESULT IN INTERRUPTIONS TO PATIENT MONITORING. THE BOOT UP ISSUE AND THE ACCOMPANYING ERROR MESSAGE INDICATES FAILURE OF THE HARD DRIVES. AS THE DEVICE WAS INSTALLED AT THE CUSTOMER'S FACILITY ON (B)(6) 2010 AND HAS NO PREVIOUS COMPLAINT HISTORY OR SERVICE HISTORY, THE ROOT CAUSE OF THE HARD DRIVE FAILURE IS MOST LIKELY RELATED TO NORMAL WEAR AND TEAR. A CAPA IS REQUIRED PER COMPLAINT HANDLING, (B)(4) IN THIS CASE. HOWEVER, AS THE ROOT CAUSE IS UNLIKELY TO BE CAUSED BY A DEFICIENCY IN DESIGN OR MANUFACTURING, A CAPA IS NOT WARRANTED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: TELEMETRY TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECEIVED A "WINDOWS SYSTEM ERROR. DISC BOOT FAILURE, ENTER SYSTEM DISK AND RE-BOOT" AND THEN THE UNIT WAS BOOTED INTO A BLACK SCREEN AND WOULD NOT LOAD THE SOFTWARE. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) DETERMINED THAT THE UNIT WAS NO LONGER READING THE HARD DISK DRIVE (HDD). THE UNIT WAS AT ITS END OF LIFE, AND THERE WERE NO REPLACEMENT HDDS. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECEIVED A "WINDOWS SYSTEM ERROR. DISC BOOT FAILURE, ENTER SYSTEM DISK AND RE-BOOT" AND THEN THE UNIT WAS BOOTED INTO A BLACK SCREEN AND WOULD NOT LOAD THE SOFTWARE. NIHON KOHDEN TECHNICAL SUPPORT (TS) DETERMINED THAT THE UNIT IS NO LONGER READING THE HARD DISK DRIVE (HDD). THE UNIT IS AT END OF LIFE, AND THERE ARE NO REPLACEMENT HDDS. TS SUGGESTED THAT THEY BUY A NEW CNS. THE BIOMED STATED THAT THERE WAS A TOTAL OF 3 OR 4 PATIENTS BEING MONITORED ON TELEMETRY TRANSMITTERS ON CHANNELS 1 THRU 8. THESE TWO CNSS ARE NOT THE PRIMARY CNSS WHICH MONITOR THESE TELEMETRY BEDS. THEY ARE USED IN CONJUNCTION (WITH OTHERS), SO THEY DID NOT HAVE ANY MONITORING INTERRUPTIONS. THEY ALSO MENTIONED THAT THEY WERE ABLE TO GET THE UNIT RUNNING AGAIN AND IS CURRENTLY USING IT. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: 3 OR 4 TELEMETRY TRANSMITTERS WERE BEING USED IN CONJUNCTION WITH THE CNS, BUT NO MODEL OR SERIAL NUMBER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECEIVED A "WINDOWS SYSTEM ERROR. DISC BOOT FAILURE, ENTER SYSTEM DISK AND RE-BOOT" AND THEN THE UNIT WAS BOOTED INTO A BLACK SCREEN AND WOULD NOT LOAD THE SOFTWARE. NIHON KOHDEN TECHNICAL SUPPORT (TS) DETERMINED THAT THE UNIT IS NO LONGER READING THE HARD DISK DRIVE (HDD). THE UNIT IS AT END OF LIFE, AND THERE ARE NO REPLACEMENT HDDS. TS SUGGESTED THAT THEY BUY A NEW CNS. THE BIOMED STATED THAT THERE WAS A TOTAL OF 3 OR 4 PATIENTS BEING MONITORED ON TELEMETRY TRANSMITTERS ON CHANNELS 1 THRU 8. THESE TWO CNSS ARE NOT THE PRIMARY CNSS WHICH MONITOR THESE TELEMETRY BEDS. THEY ARE USED IN CONJUNCTION (WITH OTHERS), SO THEY DID NOT HAVE ANY MONITORING INTERRUPTIONS. THEY ALSO MENTIONED THAT THEY WERE ABLE TO GET THE UNIT RUNNING AGAIN AND IS CURRENTLY USING IT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574741 CNS-9700A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700A NA 04931921000663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TELEMETRY TRANSMITTERS| TELEMETRY TRANSMITTERS