BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700A

    MDR report key: 5433641 · Received February 12, 2016

    Report

    Report Number
    8030229-2016-00056
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    January 9, 2016
    Report Date
    January 12, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL MONITORING SYSTEM) DID NOT ALARM FOR VENTRICULAR TACHYCARDIA. 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 Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE CNS (CENTRAL MONITORING SYSTEM) DID NOT ALARM FOR VENTRICULAR TACHYCARDIA. THE DEVICE WAS NEVER SENT IN FOR EVALUATION. USING THIS ANALYSIS, EACH QSR IS DETERMINED WITH RESPECT TO THE FIRST TRACE AND A SECOND TRACE WAVEFORM, AND COMPREHENSIVE QRS LABEL IS DETERMINED BY INTEGRATING THE RESULTS. IN THIS SITUATION THE FIRST TRACE WAS DETERMINED AS N (OR NORMAL), THE SECOND TRACE WAS DETERMINED AS V (OR VENTRICULAR), AND THE COMPREHENSIVE QRS LABEL WAS N OR "?" (INDETERMINANT). THEREFORE, THE ALARM DID NOT SOUND AND THE DEVICE ACTED PER THE ALGORITHM OF THE MU-971 DEVICE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CNS (CENTRAL MONITORING SYSTEM) DID NOT ALARM FOR VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92847 CNS-9700A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700A

    Patients

    Seq Age Sex Outcome Treatment
    1