BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 8901925 · Received August 16, 2019

    Report

    Report Number
    8030229-2019-00381
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 26, 2019
    Report Date
    July 27, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    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 GZ TELEMETRY SYSTEM WAS DOWN - EXPERIENCING COMMUNICATION LOSS AS DISPLAYED ON THE CNS. THE LOSS OF COMMUNICATION BETWEEN THE BEDSIDE AND THE CNS AFFECTS LIVE DATA, ECG AND ALARM FUNCTIONALITY. THIS MAY RESULT IN OVERLOOKING PATIENT'S CONDITION. THE CNS DEVICE IS DESIGNED SO THAT WHEN THERE IS A COMMUNICATION BREAKDOWN, A MESSAGE ON THE SCREEN NOTIFIES THE USER OF THE ISSUE: "COMMUNICATION LOSS." SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK SCORE IS MEDIUM. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, THE ISSUE HAS SINCE BEEN RESOLVED WITH A NEW SERVER. THE ISSUE WAS NOT RELATED TO INDIVIDUAL PATIENT MONITORING DEVICES, BUT RATHER NETWORKING RELATED. SINCE THE ISSUE HAS NOT RE-OCCURRED, NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR WIRELESS TELEMETRY IS DOWN AND SHOWING COMMUNICATION LOSS ON THE CENTRAL NURSE'S STATION (CNS).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR WIRELESS TELEMETRY IS DOWN AND SHOWING COMMUNICATION LOSS ON THE CENTRAL NURSE'S STATION (CNS) WHILE MONITORING GZ TRANSMITTERS. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR WIRELESS TELEMETRY IS DOWN AND SHOWING COMMUNICATION LOSS ON THE CENTRAL NURSE'S STATION (CNS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694955 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTERS| GZ TRANSMITTERS