BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12493164 · Received September 18, 2021

    Report

    Report Number
    8030229-2021-01686
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    August 19, 2021
    Report Date
    April 12, 2023
    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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMM LOSS WITH THE BEDS IN THE ICU FOLLOWING A STORM THAT CREATED A POWER SURGE, CAUSING THE HOST 1000 SERVER TO GO DOWN. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NKTS) REACHED OUT TO CLINICAL (CITS) TO REMOTE INTO THE SERVER. CITS PERFORMED TROUBLESHOOTING AND RECOMMENDED THE CUSTOMER POWER CYCLE THE MEDIA CONVERTER, WHICH RESOLVED THE ISSUE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. A POWER SURGE AT THE FACILITY CAUSED AN UNGRACEFUL EXIT TO THE SERVER CAUSING THE HOST1000 TO LOSE COMMUNICATION. A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS A REOCCURRENCE OF THE REPORTED ISSUE (TICKET 161539), WHICH WAS DETERMINED TO BE USER ERROR. BECAUSE MOST NETWORK AND COMM LOSS ISSUES ARE DUE TO HOSPITAL NETWORK SETTINGS, CONNECTION ERRORS, OR OTHER USE ERRORS, ISSUES OF THIS TYPE ARE UNLIKELY TO BE CAUSED BY A DEVICE MALFUNCTION. DUE TO THE COMPLEX NATURE OF HOSPITAL NETWORK SYSTEMS, THESE ISSUES MAY RECUR DESPITE CORRECTLY FUNCTIONING EQUIPMENT.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMM LOSS WITH THE BEDS IN THE ICU FOLLOWING A STORM THAT CREATED A POWER SURGE, CAUSING THE HOST 1000 SERVER TO GO DOWN. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE COMMUNICATION LOSS FOR BEDS BEING MONITORED BY THIS CENTRAL NURSE'S STATION (CNS) IN ICU. THERE WAS A STORM THAT CAUSED A POWER SURGE, AND THEIR HOST 1000 WENT DOWN. NIHON KOHDEN FIELD SUPPORT WAS AT THE SITE AND CHECKED THE 2ND FLOOR PACU CLOSET AND FOUND THAT THE MEDIA CONVERTER HAD GONE DOWN BECAUSE OF THE POWER SURGE. THEY POWER CYCLED THE MEDIA CONVERTER. AFTER THAT, HE CAN MONITOR ALL BEDS ON THE ICU CNS. ISSUE RESOLVED AT 7 PM PST. ISSUE WAS RESOLVED BY DISCONNECTING AND RECONNECTING THE POWER PLUG TO THE MEDIA CONVERTER ON THE 2ND FLOOR PACU CLOSET. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390778 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown