BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9316259 · Received November 13, 2019

    Report

    Report Number
    8030229-2019-00643
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 17, 2019
    Report Date
    February 18, 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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: CUSTOMER AT MERCY HEALTH PARTNERS REPORTED THE FOLLOWING ISSUE: 10/17 @1431 COMM LOSS 5 SECONDS THIS WAS PROVIDED TO NKA TECHNICAL SUPPORT (TS) FROM THE HOSPITAL'S DEPARTMENT LOGS. NO FURTHER INFORMATION WILL BE PROVIDED FROM THE HOSPITAL. INVESTIGATION CONCLUSION: THERE WAS A DOCUMENTED INCIDENT IN WHICH THE CNS WAS REPORTED TO HAVE COMMUNICATION LOSS. THE DETAILS SURROUNDING THE INCIDENT WERE NOT PROVIDED AND INFORMATION ON THE EXTENT OF ANY TROUBLESHOOTING IS UNKNOWN. 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 CUSTOMER WAS NOT WILLING TO PROVIDE FURTHER INFORMATION. THIS WAS CONFIRMED UNDER NOTIFICATION 300182278 (TICKET 68647). AS INFORMATION NEEDED TO CONDUCT AN INVESTIGATION IS NOT AVAILABLE, NO ROOT CAUSE ANALYSIS OR RISK ASSESSMENT COULD BE PERFORMED. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT. D4 LOT NUMBER & EXPIRATION DATE. THE FOLLOWING INFORMATION IS LISTED AS NO INFORMATION (NI) ON THE MDR FORM AS NO OTHER INFORMATION WILL BE PROVIDED FROM THE CUSTOMER. D4 SERIAL NUMBER. F9 AGE OF THE DEVICE. H4 DEVICE MANUFACTURE DATE. ADDITIONAL DEVICE INFORMATION: D11 & C2 CONCOMITANT MEDICAL DEVICE INFORMATION: THE CUSTOMER STATED THAT THE CNS WAS MONITORING GZ TELEMETRY TRANSMITTERS, BUT NO MODEL OR SERIAL NUMBERS WERE PROVIDED. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT. F7. TYPE OF REPORT. F11. DATE REPORT SENT TO FDA. F13. DATE REPORT SENT TO MANUFACTURER. G4. DATE RECEIVED BY MANUFACTURER. G7. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE? H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 7, 6TH FLOOR (B)(6) 2019 AT 1431 COMM LOSS 5 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 7, 6TH FLOOR (B)(6) 2019 AT 1431 COMM LOSS 5 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. 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. CONCOMITANT MEDICAL DEVICE INFORMATION: THE CUSTOMER STATED THAT THE CNS WAS MONITORING GZ TELEMETRY TRANSMITTERS, BUT NO MODEL OR SERIAL NUMBERS WERE PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 7, 6TH FLOOR (B)(6) 2019 AT 1431 COMM LOSS 5 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108530 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTERS| GZ TRANSMITTERS