BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9177289 · Received October 10, 2019

    Report

    Report Number
    8030229-2019-00558
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 16, 2019
    Report Date
    December 18, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON 09/16/19, CUSTOMER AT(B)(6) REPORTED THE CNS (PU-681RA SN: (B)(4)) DID NOT ALARM FOR VENTRICULAR TACHYCARDIA (V-TACH) WHEN IT SHOULD HAVE. THE SYSTEM DID ACKNOWLEDGE THE ARRHYTHMIA BUT DID NOT ALARM. THE UNIT'S ALARMING FUNCTIONALITY WAS VERIFIED TO BE WORKING. THE CUSTOMER VERIFIED THAT THE V-TACH ALARM WAS ON. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED: TROUBLESHOOTING/ASSISTANCE. INVESTIGATION RESULT: THE CNS WARRANTY BEGAN 12/30/18. REVIEW OF THE DEVICE C4C HISTORY FOUND NO ADDITIONAL ISSUES REPORTED RELATING TO ALARMS. PER THE ATTACHED SCL CUSTOMER COMMUNICATION, THE ARRHYTHMIA WAS NOT REPORTED BECAUSE THE BEATS WERE ASSESSED BY THE DEVICE AS BEING PACED BEATS OR (P) AS NOTED IN THE ARRHYTHMIA RECALL. CUSTOMER WAS PROVIDED THE ARRHYTHMIA MONITORING ANALYSIS ALGORITHM FOR ADDITIONAL DETAILS ON HOW THE DEVICE DETECTS, INTERPRETS, AND REPORTS VARIOUS ARRHYTHMIA. TRENDING OF "V-TACH" ISSUES REPORTED AT SCL HEALTH SYSTEM REVEALED THE FOLLOWING: ID CREATED ON PRODUCT ID DESCRIPTION 4125 11/20/2017 12:14 AM PU-621RA [MIGRATION] - (B)(6) HAS SOME QUESTIONS REGARDING THE TACHYCARDIA ALARM & SETTING LIMITSON IT. 56674 04/16/2019 05:10 PM PU-681RA CNS V-TACH ALARM - CNS-6801A, SN: (B)(4). 54913 03/27/2019 10:27 AM PU-621RA V TACT DID NOT ALARM. 68331 09/16/2019 10:19 AM PU-681RA UNIT DID NOT ALARM V TACH . REVIEW OF CUSTOMER'S REGISTERED PRODUCTS FOUND 55 PU-621RA/PU-681RA UNITS WHICH HAVE ACTIVE STATUS. THE OCCURRENCE OF 3 REPORTED ISSUES RELATING TO VENTRICULAR TACHYCARDIA AMONG 55 ACTIVE CNS UNITS DOES NOT SUGGEST AN ADVERSE TREND. THE ROOT CAUSE IS DETERMINED TO BE USER MISUNDERSTANDING OF DEVICE SETTINGS AND FUNCTIONALITY. FROM THE INFORMATION PROVIDED, THE DEVICE WAS OPERATING WITHIN ITS INTENDED SPECIFICATIONS. INVESTIGATION CONCLUSION: THE ROOT CAUSE IS DETERMINED TO BE USER MISUNDERSTANDING OF DEVICE SETTINGS AND FUNCTIONALITY. FROM THE INFORMATION PROVIDED, THE DEVICE WAS OPERATING WITHIN ITS INTENDED SPECIFICATIONS.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR A CONFIRMED PATIENT VTACH EVENT WHEN IT SHOULD HAVE. THE SYSTEM DID ACKNOWLEDGE THE ARRHYTHMIA BUT DID NOT ALARM. THE ALARM ITSELF HAS BEEN VERIFIED AS WORKING. CUSTOMER ALSO VERIFIED THAT THE VTACH ALARM WAS INDEED TURNED ON. PATIENT IS ON A PACEMAKER. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR A CONFIRMED PATIENT VTACH EVENT WHEN IT SHOULD HAVE. THE SYSTEM DID ACKNOWLEDGE THE ARRHYTHMIA BUT DID NOT ALARM. THE ALARM ITSELF HAS BEEN VERIFIED AS WORKING. CUSTOMER ALSO VERIFIED THAT THE VTACH ALARM WAS INDEED TURNED ON. PATIENT IS ON A PACEMAKER. 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: CONCOMITANT MEDICAL DEVICE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM FOR A CONFIRMED PATIENT VTACH EVENT WHEN IT SHOULD HAVE. THE SYSTEM DID ACKNOWLEDGE THE ARRHYTHMIA BUT DID NOT ALARM. THE ALARM ITSELF HAS BEEN VERIFIED AS WORKING. CUSTOMER ALSO VERIFIED THAT THE VTACH ALARM WAS INDEED TURNED ON. PATIENT IS ON A PACEMAKER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968875 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1