BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9126427 · Received September 26, 2019

    Report

    Report Number
    8030229-2019-00494
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 3, 2019
    Report Date
    July 28, 2021
    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 COMPLAINT: THE CUSTOMER REPORTED THAT THE GZ TELEMETRY DEVICE WAS SPONTANEOUSLY DISCHARGED FROM THE CENTRAL NURSE'S STATION (CNS). THE DISCHARGE AFFECTS LIVE DATA, ECG, AND ALARM FUNCTIONALITY. THIS MAY RESULT IN OVERLOOKING THE PATIENT'S CONDITION. WHEN A PATIENT IS DISCHARGED FROM THE CNS, IT WOULD INDICATE THAT THE BED TILE IS BLANK. WHEN THE CNS IS MONITORING THE PATIENT, WAVEFORMS AND VITAL SIGNS WOULD POPULATE. THE ISSUE IS READILY DETECTABLE TO THE MONITORING CLINICIAN. DEVICE LOGS WERE SENT TO NKC FOR ANALYSIS. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: ANALYSIS OF THE CNS LOG FILES. ALTHOUGH THE LOG WAS CHECKED, THE CAUSE COULD NOT BE SPECIFIED. THE LOGS WHICH THE ADMIT/DISCHARGE WINDOW HAS BEEN OPENED ON THE GZ CAN BE STORED, BUT THE LOGS WHICH THE ADMIT/DISCHARGE OPERATION HAS BEEN DONE CANNOT BE STORED. ALSO, THE ADMITTING/DISCHARGING LOGS ON THE GZ ARE NOT STORED ON THE CNS, SO IT IS DIFFICULT TO INVESTIGATE FURTHER BY THE LOGS. INVESTIGATION SUMMARY: THE OVERALL RISK SCORE IS MEDIUM. BASED ON THE ANALYSIS, THE ROOT CAUSE IS LIKELY ACCIDENTAL DISCHARGE BY PATIENT, ALTHOUGH NOT CONFIRMED BECAUSE THE LOG OF THE ADMIT/DISCHARGE OPERATION IS NOT AVAILABLE IN THE CURRENT VERSION OF THE SOFTWARE. THE RECOMMENDED CORRECTION IS USING THE AVAILABLE SCREEN LOCK FUNCTION TO PREVENT FUTURE ACCIDENTAL DISCHARGE. SERVICE HISTORY FOR THIS CUSTOMER SITE SHOWS NO SUBSEQUENT REPORTS FOR ACCIDENTAL DISCHARGE. NO CAPA IS REQUIRED AT THIS TIME. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: D4 LOT # & EXPIRATION DATE G4 DEVICE BLA NUMBER THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: CONCOMITANT MEDICAL DEVICE INFORMATION WAS REQUESTED AND THE CUSTOMER WAS NOT SURE IF IT WAS A GZ TRANSMITTER OR A CSM-1901 BEDSIDE MONITOR. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 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 THE CENTRAL NURSE'S STATION (CNS) WAS DISCHARGING PATIENTS WITHOUT USER INTERVENTION AND WHEN RE-ADMITTING PATIENTS, THE PATIENT NAME WOULD NOT APPEAR IN THE APPROPRIATE TILE. VITALS WERE DISPLAYING PROPERLY, ONLY THE NAME WOULD NOT APPEAR. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISCHARGING PATIENTS WITHOUT USER INTERVENTION AND WHEN RE-ADMITTING PATIENTS, THE PATIENT NAME WOULD NOT APPEAR IN THE APPROPRIATE TILE. VITALS WERE DISPLAYING PROPERLY, ONLY THE NAME WOULD NOT APPEAR. THIS ISSUE IS STILL UNDER INVESTIGATION. 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 WAS REQUESTED AND THE CUSTOMER WAS NOT SURE IF IT WAS A GZ TRANSMITTER OR A CSM-1901 BEDSIDE MONITOR.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISCHARGING PATIENTS WITHOUT USER INTERVENTION AND WHEN RE-ADMITTING PATIENTS, THE PATIENT NAME WOULD NOT APPEAR IN THE APPROPRIATE TILE. VITALS WERE DISPLAYING PROPERLY, ONLY THE NAME WOULD NOT APPEAR. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918066 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTER OR CSM BEDSIDE| GZ TRANSMITTER OR CSM BEDSIDE