BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9137655 · Received September 30, 2019

    Report

    Report Number
    8030229-2019-00501
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 6, 2019
    Report Date
    December 5, 2019
    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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT : ON (B)(6) 2019, CUSTOMER AT (B)(6) HEALTH PARTNERS REPORTED THE CNS-6801A (PU-681RA SN: (B)(6) ) HAD INTERMITTENT COMMUNICATION LOSS. THIS WAS REPORTED TO OCCUR FOR THE LAST 4 MONTHS ON 4 CENTRAL STATIONS. THE OUTAGES WERE BETWEEN 1 TO 10 SECONDS. THE LAST FEW OUTAGES WERE REPORTED TO OCCUR THE PREVIOUS NIGHT AT MIDNIGHT, 1AM, 2AM, AND 3AM. THE 3 OTHER CNS'S INVOLVED ARE: PU-681RA SN: (B)(6), PU-681RA SN: (B)(6), PU-681RA SN: (B)(6). SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED: CUSTOMER WAS PROVIDED INSTRUCTIONS ON HOW TO EXTRACT THE LOG FILES FROM THE CNS'S. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER. ON 11/14/19, CUSTOMER RESPONDED TO THE THIRD FOLLOW UP REPORTING THE INTERMITTENT COMMUNICATION LOSS SEEMED TO HAVE SUBSIDED AND THAT THE PROBLEM WAS NO LONGER AN ISSUE. FURTHER DETAILS WERE REQUESTED ON WHAT TROUBLESHOOTING WAS PERFORMED HOWEVER NO RESPONSE WAS PROVIDED. INVESTIGATION RESULT THE CNS WARRANTY BEGAN 03/02/19. REVIEW OF DEVICE C4C HISTORY FOUND ONE PREVIOUSLY REPORTED ISSUE RELATING TO COMMUNICATION LOSS: 62543 REPORTED 07/09/19.: ALL DEVICES ON THE CNS WERE REPORTED TO BE IN COMMUNICATION LOSS. INVESTIGATION WAS LIMITED AS SYSTEM LOGS WERE NOT AVAILABLE AND THE ROOT CAUSE COULD NOT BE DETERMINED. TRENDING OF TICKETS OPENED AT MERCY HEALTH PARTNERS FOUND 14 REPORTED INCIDENCES OF "COMM/COMMUNICATION LOSS" BETWEEN (B)(6) 2018 TO (B)(6) 2019. ID DESCRIPTION CREATED ON PRODUCT ID 43974 SPONTANEOUS RESTARTS AND COMM LOSS (B)(6) 2018 10:20 AM MU-631RA 59594 COMMUNICATION LOSS ON GZ TELEMETRY 05/28/2019 02:01 AM PU-681RA 61204 COMM LOSS ON ALL GZ'S AND COMM LOSS ON ALL RNS (B)(6) 2019 06:13 PM PU-681RA 63981 TILES ARE INTERMITTENTLY SHOWING COMM LOSS (B)(6) 2019 09:51 PM A/RNS-9703-242 58093 5 RNS IN INTERMITTENT COMM LOSS (B)(6) 2019 09:31 PM A/RNS-9703-242 60045 COMM LOSS (B)(6) 2019 03:54 AM PU-681RA 60488 COMM LOSS (B)(6) 2019 08:38 AM PU-681RA 62543 COMM LOSS ON ALL THEIR CNS, TELE GZ (B)(6) 2019 11:16 PM PU-681RA 64272 COMMUNICATION LOSS ON ALL TELES ON .40 "D" SEGMENT (B)(6) 2019 03:42 PM PU-681RA 59342 GZ DEVICES IN COMM LOSS (B)(6) 2019 05:35 AM GZ-130PA 59443 COMM LOSS (B)(6) 2019 08:00 AM GZ-130PA 59444 COMM LOSS (B)(6) 2019 08:02 AM GZ-130PA 65313 GZ TELE IN COMM LOSS (B)(6) 2019 09:57 PM PU-681RA 67704 INTERMITTANT COMM LOSS ON ALL CENTRAL STATIONS LEVEL 6 (B)(6) 2019 10:30 AM PU-681RA NO FURTHER COMMUNICATION LOSS WAS REPORTED AFTER (B)(6) 2019. THE CNS LOGS WERE NOT PROVIDED FOR THE INVESTIGATION. THE COMMUNICATION LOSS WAS REPORTED TO HAVE SUBSIDED HOWEVER NO FURTHER INFORMATION WAS PROVIDED ON WHAT CHANGES WERE MADE AT THE HOSPITAL. FROM THE AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: THE CNS LOGS WERE NOT PROVIDED FOR THE INVESTIGATION. THE COMMUNICATION LOSS WAS REPORTED TO HAVE SUBSIDED HOWEVER NO FURTHER INFORMATION WAS PROVIDED ON WHAT CHANGES WERE MADE AT THE HOSPITAL. FROM THE AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT 4 CENTRAL NURSE'S STATIONS (CNS) EXPERIENCED INTERMITTENT SIGNAL LOSS FOR ABOUT 1-10 SECONDS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT 4 CENTRAL NURSE'S STATIONS (CNS) EXPERIENCED INTERMITTENT SIGNAL LOSS FOR ABOUT 1-10 SECONDS. THE CUSTOMER ALSO REPORTED THAT THEY HAVE DEALT WITH SIMILAR ISSUES IN THE PAST 4 MONTHS, ALTHOUGH THEY NEVER REPORTED IT. 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. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL PRODUCT: THE FOLLOWING CONCOMITANT MEDICAL PRODUCTS WERE USED IN CONJUNCTION WITH THE CNS, AND ARE THE DEVICES THAT EXPERIENCED FAILURE: CNS - MODEL: PU-681RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 17 MONTHS, DEVICE MANUFACTURER DATE: 04/20/2018, UNIQUE IDENTIFIER (UDI) #: (B)(4). CNS - MODEL: PU-681RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 17 MONTHS, DEVICE MANUFACTURER DATE: 04/23/2018, UNIQUE IDENTIFIER (UDI) #: (B)(4). CNS - MODEL: PU-681RA, S/N: (B)(4), APPROXIMATE AGE OF THE DEVICE: 17 MONTHS, DEVICE MANUFACTURER DATE: 04/24/2018, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 4 CENTRAL NURSE'S STATIONS (CNS) EXPERIENCED INTERMITTENT SIGNAL LOSS FOR ABOUT 1-10 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928882 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 3 CNS'S| 3 CNS'S