BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 8936473 · Received August 27, 2019

    Report

    Report Number
    8030229-2019-00406
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 31, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS WERE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). THEY WERE EXPERIENCING WIDESPREAD SIGNAL LOSS ON TWO SEPARATE FLOORS ACROSS MANY DEVICES SEEMINGLY AT RANDOM. THIS ISSUE WAS INTERMITTENT IN NATURE AND THE SIGNAL LOSS WAS MOMENTARY. A FEW INSTANCES OF SIGNAL LOSS HAVE GONE OVER A MINUTE. ISSUES HAVE BEEN OCCURRING SINCE THE INSTALL BUT HAVE GROWN WORSE IN THE LAST COUPLE OF DAYS OF REPORTING THIS TO NK. ONE CNS WAS MONITORING 24 TELEMETRY TRANSMITTERS, AND ANOTHER CNS WAS MONITORING A PREFENSE (EDNS-9001) MONITOR WHICH WAS MONITORING 8 TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK OF THIS EVENT IS DETERMINED TO BE HIGH. THE ROOT CAUSE CANNOT BE DETERMINED. A POSSIBLE ROOT CAUSE IS IMPROPER INSTALLATION AS MULTIPLE INSTANCES OF INSTALLATION ISSUES WERE IDENTIFIED BY NK EMPLOYEES. DUE TO THE AGE OF THIS COMPLAINT, NO ADDITIONAL INFORMATION CAN BE OBTAINED FROM THE CUSTOMER, (REFERENCE CAPA 20-004). AS THIS ISSUE HAS AN OVERALL RISK SCORE OF HIGH, A CAPA IS REQUIRED PER CORRECTIVE ACTION AND PREVENTIVE ACTION PROCESS, SOP07-003. SINCE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CAPA IS INITIATED. WITHOUT A ROOT CAUSE, THE COUNTER MEASURE TO PREVENT RECURRENCE CANNOT BE PERFORMED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: CNS: MODEL #: CNS-6201A (PU-621RA). SERIAL #: (B)(6). MULTIPLE PATIENT RECEIVER (ORG): MODEL #: ORG-9100A. SERIAL #S: (B)(6). TRANSMITTERS: MODEL #: NI. SERIAL #: NI. CORRECTED INFORMATION: H2 IF FOLLOW-UP, WHAT TYPE?: "ADDITIONAL INFORMATION" WAS NOT SELECTED IN FU 001, BUT WAS INCLUDED IN THE "ADDITIONAL INFORMATION" LIST IN H10. IT IS NOW CORRECTED TO REFLECT THAT ADDITIONAL INFORMATION WAS ADDED IN THE PREVIOUS FU.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS WERE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). THEY WERE EXPERIENCING WIDESPREAD SIGNAL LOSS ON TWO SEPARATE FLOORS ACROSS MANY DEVICES SEEMINGLY AT RANDOM. THIS ISSUE WAS INTERMITTENT IN NATURE AND THE SIGNAL LOSS WAS MOMENTARY. A FEW INSTANCES OF SIGNAL LOSS HAVE GONE OVER A MINUTE. ISSUES HAVE BEEN OCCURRING SINCE THE INSTALL BUT HAVE GROWN WORSE IN THE LAST COUPLE OF DAYS OF REPORTING THIS TO NK. ONE CNS WAS MONITORING 24 TELEMETRY TRANSMITTERS, AND ANOTHER CNS WAS MONITORING A PREFENSE (EDNS-9001) MONITOR WHICH WAS MONITORING 8 TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK OF THIS EVENT IS DETERMINED TO BE HIGH. THE ROOT CAUSE CANNOT BE DETERMINED. A POSSIBLE ROOT CAUSE IS IMPROPER INSTALLATION AS MULTIPLE INSTANCES OF INSTALLATION ISSUES WERE IDENTIFIED BY NK EMPLOYEES. DUE TO THE AGE OF THIS COMPLAINT, NO ADDITIONAL INFORMATION CAN BE OBTAINED FROM THE CUSTOMER, (REFERENCE CAPA 20-004). AS THIS ISSUE HAS AN OVERALL RISK SCORE OF HIGH, A CAPA IS REQUIRED PER CORRECTIVE ACTION AND PREVENTIVE ACTION PROCESS, SOP07-003. SINCE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CAPA IS INITIATED. WITHOUT A ROOT CAUSE, THE COUNTER MEASURE TO PREVENT RECURRENCE CANNOT BE PERFORMED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: CNS: MODEL #: CNS-6201A (PU-621RA). SERIAL #: (B)(6). MULTIPLE PATIENT RECEIVER (ORG): MODEL #: ORG-9100A. SERIAL #S: (B)(6). TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS ARE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS ARE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS ARE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). THEY WERE EXPERIENCING WIDESPREAD SIGNAL LOSS ON TWO SEPARATE FLOORS ACROSS MANY DEVICES SEEMINGLY AT RANDOM. THIS ISSUE IS INTERMITTENT IN NATURE AND THE SIGNAL LOSS IS MOMENTARY. A FEW INSTANCES OF SIGNAL LOSS HAVE GONE OVER A MINUTE. ISSUES HAVE BEEN OCCURRING SINCE THE INSTALL BUT HAVE GROWN WORSE IN THE LAST COUPLE OF DAYS OF REPORTING THIS TO NK. ONE CNS WAS MONITORING 24 TELEMETRY TRANSMITTERS, AND ANOTHER CNS WAS MONITORING A PREFENSE (EDNS-9001) CENTRAL NURSE STATION WHICH WAS MONITORING 8 TELEMETRY TRANSMITTERS. NIHON KOHDEN TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND AS THAT DID NOT RESOLVE THE ISSUE, NK WENT ON SITE TO DO AN ASSESSMENT. THE ROOT CAUSE IS NOT FULLY DETERMINED YET BUT MULTIPLE INSTALLATION ISSUES HAVE BEEN FOUND. NK IS STILL WORKING TO RESOLVE THE ISSUE. PATIENTS HAVE BEEN MOVED FROM THESE AREAS DUE TO THE INTERMITTENT SIGNAL LOSS ISSUES. 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: CNS-6201A, (PU-621RA), SN (B)(4). ORG-9100A, SN (B)(4), MULTIPLE PATIENT RECEIVER. ORG-9100A, SN (B)(4), MULTIPLE PATIENT RECEIVER. ORG-9100A, SN (B)(4), MULTIPLE PATIENT RECEIVER. ORG-9100A, SN (B)(4), MULTIPLE PATIENT RECEIVER. TELEMETRY TRANSMITTER INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED THE MODELS AND SERIAL NUMBERS OF THE DEVICES THAT WERE IN USE AT THE TIME OF THIS ISSUE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT 32 TELEMETRY TRANSMITTERS ARE EXPERIENCING INTERMITTENT SIGNAL LOSS WITH THE 2 CENTRAL NURSE'S STATIONS (CNS). NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727858 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 CNS-6201A SN (B)(6)| CNS-6201A SN (B)(6) | CNS-6201A SN (B)(6) | EDNS-9001 SN UNKNOWN| EDNS-9001 SN UNKNOWN| EDNS-9001 SN UNKNOWN| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)| ORG-9100A SN (B)(6)