BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-2101 CENTRAL MONITOR

    MDR report key: 19277571 · Received May 9, 2024

    Report

    Report Number
    8030229-2024-04267
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 15, 2024
    Report Date
    August 5, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921017159
    PMA / PMN Number
    K223567
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THE CENTRAL NURSES STATION (CNS) SPONTANEOUSLY WENT TO A BLUE SCREEN AND THEN REBOOTED. THEY ESTIMATED THE CNS WAS DOWN FOR LESS THAN 45 MINUTES. THEY WILL SEND THE LOG FILES IN FOR EVALUATION BY NK. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE LOGS WERE INVESTIGATED AND REVIEWED BY NIHON KOHDEN (NKC) AND FOUND THAT THE SYSTEM REBOOTED ITSELF DUE TO THE SCREEN CONTROL APPLICATION CRASHING. A DEFINITIVE ROOT CAUSE FOR THE APPLICATION CRASHING COULD NOT BE DETERMINED BUT IT MAY HAVE BEEN DERIVED FROM HIGH OPERATIONAL LOAD ON THE SYSTEM. NKC RECOMMENDED UPGRADING THE CNS SOFTWARE TO VERSION 02-03 TO PREVENT RECURRENCE SINCE IT INCLUDES SOFTWARE IMPROVEMENTS TO SUPPORT HIGHER LOADS. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER DOES NOT SHOW RECURRENCE OR OTHER SIMILAR COMPLAINTS. REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DOES NOT SHOW ANY TRENDS FOR THIS ISSUE AND DEVICE. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS: MODEL #: GZ-130S. SERIAL #: NI. DEVICE MANUFACTURER DATA:NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CNS-6201A TO CNS-2101 CENTRAL MONITOR. D2B DEVICE PRODUCT CODE: CORRECTED THE PRODUCT CODE FROM MSX TO MHX. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-2101A TO CNS-2101. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM CNS-2101A TO CNS-2101. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PI INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, APPLICABLE TO THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION OF THE FDA FORM 3500A.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE CENTRAL NURSES STATION (CNS) SPONTANEOUSLY WENT TO A BLUE SCREEN AND THEN REBOOTED. THEY ESTIMATED THE CNS WAS DOWN FOR LESS THAN 45 MINUTES. THEY WILL SEND THE LOG FILES IN FOR EVALUATION BY NK. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 04/29/2024 EMAILED THE CUSTOMER FOR ALL THE INFORMATION IN THE NI LIST ABOVE: THEY REPLIED THEY WERE UNABLE TO PROVIDE ANY MORE INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS: MODEL #: GZ-130S. SERIAL #: NI. DEVICE MANUFACTURER DATA:NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CENTRAL NURSES STATION (CNS) SPONTANEOUSLY WENT TO A BLUE SCREEN AND THEN REBOOTED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CENTRAL NURSES STATION (CNS) SPONTANEOUSLY WENT TO A BLUE SCREEN AND THEN REBOOTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376654 CNS-2101 CENTRAL MONITOR CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-2101 NA 04931921017159
    469802 CNS-2101 CENTRAL MONITOR CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-2101 NA 04931921017159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GZ-130S| GZ-130S