BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12339569 · Received August 18, 2021

    Report

    Report Number
    2080783-2021-01498
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 18, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR PATIENTS THAT WERE ON DEVICES CONNECTED VIA WIFI. THE CUSTOMER STATED THE THE CNS HAS A MIX OF DEVICES, BUT MOSLY GZ-130PA'S WITH ABOUT 5 BSM-1700'S. ACCORDING TO THE CUSTOMER, BED NAME PMTELE-56 GAVE COMM LOSS MESSAGE WHEN THE VITALS SIGNS DISAPPEARED. PATIENT ON DEVICES CONNECTED VIA NETWORK CABLE HAD NO ISSUES. THE CUSTOMER HAS UPLOADED THE LOGS. THERE WAS NO PATIENT INJURY 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: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NI . BEDSIDE MONITORS (BSM'S): MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NI

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR PATIENTS THAT WERE ON DEVICES CONNECTED VIA WIFI. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237665 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 BEDSIDE MONITORS (BSM'S)| GZ TRANSMITTERS