BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12686437 · Received October 22, 2021

    Report

    Report Number
    2080783-2021-01823
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 22, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS AN INSTANCE FOR COMMUNICATION LOSS BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). WHEN THE NURSES WENT TO CHECK THE GZ TELEMETRY TRANSMITTER, THE BATTERIES WERE DEAD. THEY STATED THAT THEY DID NOT SEE A BATTERY ALARM IN THE EVENT LIST BEFORE THEY SAW THE COMM LOSS. THEY DO SEE OTHER CHANGE BATTERY MESSAGES, BUT NOT FOR THIS DAY'S EVENT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) EXPLAINED TO THE BIOMED THAT THE COMM LOSS MIGHT HAVE HAPPENED PREVIOUS TO THE BATTERIES DYING AND THAT WAS WHY THE MESSAGE NEVER CAME ACROSS. TECH SUPPORT ALSO STRESSED THE IMPORTANCE OF CHECKING ON THE DEVICE WHENEVER THE DEVICE IS ALARMING COMM LOSS. 2 GZ TELEMETRY TRANSMITTERS HAD THE ISSUES ON 09/22 AROUND 1200PM WITH COMM LOSS AND DEAD BATTERIES, BUT NO BATTERY ALARMS. TECH SUPPORT ASKED THE BIOMED TO GET THE LOG FILES. TECH SUPPORT CALLED THE CUSTOMER TO CHECK IF HE LOOKED INTO THE ESCALATION OF THE BATTERY WEAK ALARM. HE DID AND WANTED TO RUN IT BY THEIR CLINICAL EXECUTIVES BEFORE MAKING CHANGES. HE ALSO STATED THAT THERE WAS A HOSPITAL NETWORK ISSUE THAT WAS CAUSING THE COMMUNICATION LOSS. THEY LATER STATED THAT A FAULTY UPS TIED TO A SWITCH / ROUTER WAS IDENTIFIED AND REPLACED IT WAS DETERMINED THIS DID AFFECT THIS SECTION OF THE HOSPITAL'S NETWORK. NO PATIENT HARM WAS REPORTED. ATTEMPT #1: (B)(6) 2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: (B)(6) 2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3: (B)(6) 2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK BUT THEY DID NOT PROVIDE MOST OF THE INFORMATION REQUESTED. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED. TELEMETRY TRANSMITTER(S) : MODEL: GZ-130PA, SN: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS AN INSTANCE FOR COMMUNICATION LOSS BEING DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS). WHEN THE NURSES WENT TO CHECK THE GZ TELEMETRY TRANSMITTER, THE BATTERIES WERE DEAD. THEY STATED THAT THEY DID NOT SEE A BATTERY ALARM IN THE EVENT LIST BEFORE THEY SAW THE COMM LOSS. THEY DO SEE OTHER CHANGE BATTERY MESSAGES, BUT NOT FOR THIS DAY'S EVENT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) EXPLAINED TO THE BIOMED THAT THE COMM LOSS MIGHT HAVE HAPPENED PREVIOUS TO THE BATTERIES DYING AND THAT WAS WHY THE MESSAGE NEVER CAME ACROSS. TECH SUPPORT ALSO STRESSED THE IMPORTANCE OF CHECKING ON THE DEVICE WHENEVER THE DEVICE IS ALARMING COMM LOSS. 2 GZ TELEMETRY TRANSMITTERS HAD THE ISSUES ON 09/22 AROUND 1200PM WITH COMM LOSS AND DEAD BATTERIES, BUT NO BATTERY ALARMS. TECH SUPPORT ASKED THE BIOMED TO GET THE LOG FILES. TECH SUPPORT CALLED THE CUSTOMER TO CHECK IF HE LOOKED INTO THE ESCALATION OF THE BATTERY WEAK ALARM. HE DID AND WANTED TO RUN IT BY THEIR CLINICAL EXECUTIVES BEFORE MAKING CHANGES. HE ALSO STATED THAT THERE WAS A HOSPITAL NETWORK ISSUE THAT WAS CAUSING THE COMMUNICATION LOSS. THEY ARE CURRENTLY WORKING TO FIX THE ISSUE WHICH WAS AFFECTING THE GZ TELEMETRY TRANSMITTERS. THEY LATER STATED THAT A FAULTY UPS TIED TO A SWITCH / ROUTER WAS IDENTIFIED AND REPLACED IT WAS DETERMINED THIS DID AFFECT THIS SECTION OF THE HOSPITAL'S NETWORK. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576872 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1