BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 11346954 · Received February 18, 2021

    Report

    Report Number
    2080783-2021-00088
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 18, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS A PATIENT INCIDENT BETWEEN 2AM-5AM THERE WAS A PATIENT INCIDENT AND NEEDED TO RETRIEVE DATA. THE BIOMED WAS ASKED TO GET THE PATIENT INFORMATION (FULL DISCLOSURE) FROM 2AM TO 5AM. THE ONLY INFORMATION THAT THE BIOMED COULD PROVIDE WAS THAT PATIENT WAS TRANSFERRED FROM TELE EAST 507 TO CSU WEST 239 AND THAT THE INFORMATION DID NOT CROSSOVER. HE STATED THAT FULL DISCLOSURE DATA FROM FROM THE CENTRAL NURSE'S STATION (CNS) AT CSU WEST DEPT. SHOWED RECORDING STARTING AT APPROX 4:30AM FOR THAT PATIENT. HOWEVER, NO RECORDING COULD BE FOUND BETWEEN 2AM AND 4:30AM. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THAT THEY PROVIDE PATIENT DATA FROM THE CNS AT TELE EAST DEPT. TO GET A CLEARER PICTURE ON OW MUCH DATA WAS LOST. THE TRANSFER HAPPENED AT 4:29AM ON (B)(6) 2021. HE STATED THAT THE PATIENT ARRIVED FROM THE TELE DEPARTMENT TO THE CSU DEPARTMENT WITHOUT A TRANSMITTER ON HIM. TECH SUPPORT ASKED HIM IF HE KNEW HOW THE STAFF DID THE PATIENT TRANSFER. IF THEY TRANSFERRED THE PATIENT VIA USING THE TELE CNS AND DID THE PATIENT TRANSFER FROM THERE AND SELECTED WHICH BED AT THE CSU CENTRAL NURSE'S STATION (CNS) THAT THE PATIENT WOULD BE SENT TO. HE SAID THAT HE DID NOT KNOW EXACTLY HOW THEY TRANSFERRED THE PATIENT, HE HAS NO DETAILS ON IT. HE JUST KNOWS THE PATIENT WAS PHYSICALLY MOVED FROM TELE TO CSU AND THE PATIENT ARRIVED AT CSU AT 4:29AM AND WHEN THEY STARTED TO MONITOR THE PATIENT, NO DATA WAS SEEN PRIOR TO 4:30AM. THE PATIENT WAS TRANSFERRED FROM THE ROOMS TELE EAST 507 TO CSU WEST 239. THEY ALSO FOUND THAT THEY HAD ISSUES WITH THE KEYBOARD OF THIS CENTRAL NURSE'S STATION (CNS) WHEN THEY WENT TO DOWNLOAD THE DATA FROM THE UNIT. THE TOUCHSCREEN WAS WORKING. THEY COULD NOT COLLECT THE LOG FILES JUST USING THE CNS TOUCHSCREEN FUNCTIONALITY BECAUSE HE HAS TO USE THE KEYBOARD TO RENAME THE FILE ONTO THE USB DRIVE. THEY SAID HE WILL TRY THIS THE LATER AND USE A DIFFERENT KEYBOARD. WE HAVE REQUESTED DEVICE INFORMATION AS WE ONLY HAVE PLACEHOLDER DEVICE INFORMATION AND PATIENT INFORMATION WITH THE ADVERSE EVENT FORM. WE ALSO ASKED FOR CLARIFICATION ON THE DETAILS ON THE DATA LOSS. WE WERE NOT SURE IF THERE WAS AN ISSUE WITH TRANSFERRING PATIENTS FROM ONE LOCATION TO ANOTHER VIA CENTRAL NURSE'S STATION (CNS) AND IT FAILED. ON THE OTHER HAND, WE WERE NOT SURE IF THE USER DISCHARGED THE DEVICE AND THEN PHYSICALLY MOVED THE PATIENT TO ANOTHER DEPARTMENT AND THEN ADMITTED THE PATIENT THERE. THE LATTER WOULD RESULT IN DATA LOSS AND BE A USER ERROR. THE CUSTOMER HAS BEEN UNRESPONSIVE TO EMAILS REQUESTING DEVICE AND PATIENT INFORMATION. TELEMETRY TRANSMITTER MODEL: NI. SN: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS A PATIENT INCIDENT BETWEEN 2AM-5AM THERE WAS A PATIENT INCIDENT AND NEEDED TO RETRIEVE DATA. THE BIOMED WAS ASKED TO GET THE PATIENT INFORMATION (FULL DISCLOSURE) FROM 2AM TO 5AM. THE ONLY INFORMATION THAT THE BIOMED COULD PROVIDE WAS THAT PATIENT WAS TRANSFERRED FROM TELE EAST 507 TO CSU WEST 239 AND THAT THE INFORMATION DID NOT CROSSOVER. HE STATED THAT FULL DISCLOSURE DATA FROM FROM THE CENTRAL NURSE'S STATION (CNS) AT CSU WEST DEPT. SHOWED RECORDING STARTING AT APPROX 4:30AM FOR THAT PATIENT. HOWEVER, NO RECORDING COULD BE FOUND BETWEEN 2AM AND 4:30AM. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THAT THEY PROVIDE PATIENT DATA FROM THE CNS AT TELE EAST DEPT. TO GET A CLEARER PICTURE ON OW MUCH DATA WAS LOST. THE TRANSFER HAPPENED AT 4:29AM ON (B)(6) 2021. HE STATED THAT THE PATIENT ARRIVED FROM THE TELE DEPARTMENT TO THE CSU DEPARTMENT WITHOUT A TRANSMITTER ON HIM. TECH SUPPORT ASKED HIM IF HE KNEW HOW THE STAFF DID THE PATIENT TRANSFER. IF THEY TRANSFERRED THE PATIENT VIA USING THE TELE CNS AND DID THE PATIENT TRANSFER FROM THERE AND SELECTED WHICH BED AT THE CSU CENTRAL NURSE'S STATION (CNS) THAT THE PATIENT WOULD BE SENT TO. HE SAID THAT HE DID NOT KNOW EXACTLY HOW THEY TRANSFERRED THE PATIENT, HE HAS NO DETAILS ON IT. HE JUST KNOWS THE PATIENT WAS PHYSICALLY MOVED FROM TELE TO CSU AND THE PATIENT ARRIVED AT CSU AT 4:29AM AND WHEN THEY STARTED TO MONITOR THE PATIENT, NO DATA WAS SEEN PRIOR TO 4:30AM. THE PATIENT WAS TRANSFERRED FROM THE ROOMS TELE EAST 507 TO CSU WEST 239. THEY ALSO FOUND THAT THEY HAD ISSUES WITH THE KEYBOARD OF THIS CENTRAL NURSE'S STATION (CNS) WHEN THEY WENT TO DOWNLOAD THE DATA FROM THE UNIT. THE TOUCHSCREEN WAS WORKING. THEY COULD NOT COLLECT THE LOG FILES JUST USING THE CNS TOUCHSCREEN FUNCTIONALITY BECAUSE HE HAS TO USE THE KEYBOARD TO RENAME THE FILE ONTO THE USB DRIVE. THEY SAID HE WILL TRY THIS THE LATER AND USE A DIFFERENT KEYBOARD. WE HAVE REQUESTED DEVICE INFORMATION AS WE ONLY HAVE PLACEHOLDER DEVICE INFORMATION AND PATIENT INFORMATION WITH THE ADVERSE EVENT FORM. WE ALSO ASKED FOR CLARIFICATION ON THE DETAILS ON THE DATA LOSS. WE WERE NOT SURE IF THERE WAS AN ISSUE WITH TRANSFERRING PATIENTS FROM ONE LOCATION TO ANOTHER VIA CENTRAL NURSE'S STATION (CNS) AND IT FAILED. ON THE OTHER HAND, WE WERE NOT SURE IF THE USER DISCHARGED THE DEVICE AND THEN PHYSICALLY MOVED THE PATIENT TO ANOTHER DEPARTMENT AND THEN ADMITTED THE PATIENT THERE. THE LATTER WOULD RESULT IN DATA LOSS AND BE A USER ERROR. THE CUSTOMER HAS BEEN UNRESPONSIVE TO EMAILS REQUESTING DEVICE AND PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238181 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1