BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10498098 · Received September 5, 2020

    Report

    Report Number
    8030229-2020-00510
    Event Type
    Malfunction
    Date Received
    September 5, 2020
    Date of Event
    August 6, 2020
    Report Date
    February 21, 2023
    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
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR THE V-FIB CRISIS ALARMS. THE 1ST EVENT WAS 7 SECONDS LONG AND THE PRINTOUT DOCUMENTED THERE WAS INDEED A CRISIS ALARM OF V-FIB. THE 2ND EVENT WAS ALSO V-FIB LASTING 28 SECS. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER SENT IN THE DEVICE LOGS FOR NK REVIEW. THE WARNING ALARM AND THE CRISIS ALARM ARE LABELED ON THE CNS WHEN THE WARNING ALARM AND THE CRISIS ALARM ARE GENERATED. HOWEVER, WHEN IN THE STATE OF "ALARMS PAUSED" OR THE "ALL ALARMS OFF" ON THE BEDSIDE MONITOR (BSM), THE ALARM IS TREATED AS A MESSAGE AND THE WARNING ALARM AND CRISIS ALARM ARE NOT LABELED ON THE CNS AND ONLY THE ARRHYTHMIA TYPE IS DISPLAYED. AS FOR THE LABELING OF THIS V-FIB ALARM, IT WAS DETERMINED THAT IT WAS THE ALARMS GENERATED WHILE IN THE STATE OF THE "ALARMS PAUSED" OR THE "ALL ALARMS OFF" ON THE BEDSIDE MONITOR. A POSSIBLE CAUSE OF THIS ISSUE IS THAT THE USER MADE A MISTAKE IN SETTING UP THE ARRHYTHMIA ALARM. THE RISK MITIGATING FACTOR IS ENSURED IN THE DESIGN THAT THE USER IS ABLE TO SET UP APPROPRIATE ALARMS AS WELL AS THE DESCRIPTION OF THE ARRHYTHMIA ALARMS. THE SERVICE HISTORY FOR THIS SERIAL NUMBER SHOWS THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR THE V-FIB CRISIS ALARMS. 1ST EVENT 7 SEC LONG AND THE PRINT OUT DOCUMENTED THAT THERE WAS INDEED A CRISIS ALARM OF V-FIB. 2ND EVENT ALSO V-FIB LASTED 28 SECS. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR THE V-FIB CRISIS ALARMS. 1ST EVENT 7 SEC LONG AND THE PRINT OUT DOCUMENTED THAT THERE WAS INDEED A CRISIS ALARM OF V-FIB. 2ND EVENT ALSO V-FIB LASTED 28 SECS. NO PATIENT HARM 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR THE V-FIB CRISIS ALARMS. 1ST EVENT 7 SEC LONG AND THE PRINT OUT DOCUMENTED THAT THERE WAS INDEED A CRISIS ALARM OF V-FIB. 2ND EVENT ALSO V-FIB LASTED 28 SECS. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962566 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown