BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9148336 · Received October 2, 2019

    Report

    Report Number
    8030229-2019-00522
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 6, 2019
    Report Date
    December 30, 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 MERCY HEALTH PARTNERS REPORTED THE FOLLOWING ISSUE: COMM LOSS 20:01 FOR A FEW SECONDS, COMM LOSS 21:06 FOR A FEW SECONDS, COMM LOSS 23:15 FOR A FEW SECONDS, COMM LOSS 00:20 FOR A FEW SECONDS. THIS WAS PROVIDED TO NKA TECHNICAL SUPPORT (TS) FROM THE HOSPITAL'S DEPARTMENT LOGS. THE INCIDENT OCCURRED ON 09/06/19 WITH CNS (PU-681RA SN: NI). NO FURTHER INFORMATION WILL BE PROVIDED FROM THE HOSPITAL. SERVICE REQUESTED: NONE. SERVICE PERFORMED: NONE. INVESTIGATION RESULT: FURTHER INVESTIGATION OF THE ISSUE IS LIMITED AS THE DEVICE AND/OR LOGS WERE NOT RETRIEVED FOR EVALUATION, NOR WAS THE DEVICE SERIAL NUMBER PROVIDED. THE DETAILS SURROUNDING THE INCIDENT WERE NOT PROVIDED AND INFORMATION ON THE EXTENT OF ANY TROUBLESHOOTING IS UNKNOWN. THE ISSUE WAS REPORTED TO NKA 12 DAYS AFTER THE INCIDENT OCCURRED, MAKING ANY ATTEMPTS AT GATHERING ADDITIONAL INFORMATION DIFFICULT. TRENDING OF TICKETS OPENED AT MERCY HEALTH PARTNERS FOUND 14 REPORTED INCIDENCES OF "COMM/COMMUNICATION LOSS" BETWEEN 11/07/18 TO PRESENT. ID CREATED ON PRODUCT ID DESCRIPTION (B)(6), (B)(6) 2018 10:20 AM MU-631RA SPONTANEOUS RESTARTS AND COMM LOSS, (B)(6), (B)(6) 2019 02:01 AM PU-681RA COMMUNICATION LOSS ON GZ TELEMETRY, (B)(6), (B)(6) 2019 06:13 PM PU-681RA COMM LOSS ON ALL GZ'S AND COMM LOSS ON ALL RNS, (B)(6), (B)(6) 2019 09:51 PM A/RNS-9703-242 TILES ARE INTERMITTENTLY SHOWING COMM LOSS, (B)(6), (B)(6) 2019 09:31 PM A/RNS-9703-242 5 RNS IN INTERMITTENT COMM LOSS, (B)(6), (B)(6) 2019 03:54 AM PU-681RA COMM LOSS, (B)(6), (B)(6) 2019 08:38 AM PU-681RA COMM LOSS, (B)(6), (B)(6) 2019 11:16 PM PU-681RA COMM LOSS ON ALL THEIR CNS, TELE GZ, (B)(6), (B)(6) 2019 03:42 PM PU-681RA COMMUNICATION LOSS ON ALL TELES ON .40 "D" SEGMENT, (B)(6), (B)(6) 2019 05:35 AM GZ-130PA GZ DEVICES IN COMM LOSS, (B)(6), (B)(6) 2019 08:00 AM GZ-130PA COMM LOSS, (B)(6), (B)(6) 2019 08:02 AM GZ-130PA COMM LOSS, (B)(6), (B)(6) 2019 09:57 PM PU-681RA GZ TELE IN COMM LOSS, (B)(6), (B)(6) 2019 10:30 AM PU-681RA INTERMITTENT COMM LOSS ON ALL CENTRAL STATIONS LEVEL 6, NO FURTHER COMMUNICATION LOSS WAS REPORTED AFTER (B)(6) 2019, THE CUSTOMER WAS NOT WILLING TO PROVIDE FURTHER INFORMATION. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO MAKE ANY DETERMINATION OF THE ROOT CAUSE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT INTO COMM LOSS MULTIPLE TIMES WITH ALL THE DEVICES IT WAS MONITORING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT INTO COMM LOSS MULTIPLE TIMES ON ALL THE DEVICES IT WAS MONITORING. NO CONSEQUENCE OR IMPACT TO THE PATIENTS WAS REPORTED. THE CUSTOMER INDICATED THAT THEY WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION REGARDING THE EVENT. 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. BELOW IS THE EXACT DESCRIPTION OF THE CUSTOMER COMPLAINT: COMM LOSS 20:01 FOR A FEW SECONDS. COMM LOSS 21:06 FOR A FEW SECONDS. COMM LOSS 23:15 FOR A FEW SECONDS. COMM LOSS 00:20 FOR A FEW SECONDS. APPROXIMATE AGE OF DEVICE. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WENT INTO COMM LOSS MULTIPLE TIMES WITH ALL THE DEVICES IT WAS MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940948 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1