MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Loss of Data (2903); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that at the central nurse's station (cns) a patient had been discharged and they lost visibility of the patients' demographics on the cns.The bme stated the issue was resolved because they noticed the patient was discharged and that is what caused the demographics to be lost at the cns.The bme stated he had the screen lock on but when he checked out the device it was unlocked.The bme stated he also noticed a red circle next to a triangle with closed parenthesis.No patient harm was reported.The bme requested nihon kohden to investigate what caused the patient to be discharged as the monitor technicians are stating that they did not discharge the patient.The bme sent in the event logs to nihon kohden for further investigation.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.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.A2 - a6 b6 b7 attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.Customer provided the concomitant medical device involved but did not provide the patient information above.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: vital sign telemeter: model #: gz-130p.Serial #: (b)(6).Device manufacturer data: 06/23/2020.Unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that at the central nurse's station (cns) a patient had been discharged and they lost visibility of the patients' demographics on the cns.The bme stated the issue was resolved because they noticed the patient was discharged and that is what caused the demographics to be lost at the cns.The bme stated he had screen lock on but when he checked out the device it was unlocked.The bme stated he also noticed a red circle next to a triangle with closed parenthesis.No patient harm was reported.The bme requested nihon kohden to investigate what caused the patient to be discharged as the monitor technicians are stating that they did not discharge the patient.The bme sent in the event logs to nihon kohden for further investigation.

Manufacturer Narrative

Details of complaint: on 07/22/2023, the customer reported that they experienced patient demographics loss on the central nurse's station (cns), (pu-681ra, serial number (b)(4)).The customer stated the issue was resolved because they noticed the patient was discharged and that is why the demographics were lost.The customer requested an investigation of logs to determine what caused the patient to be discharged as the techs are stating they did not discharge the patient.Additionally, the customer stated the screen was locked but when he checked out the device the screen was unlocked.The customer also noticed a red circle next to a triangle with closed parenthesis.There was patient involvement when the issue occurred, but no report of injury, no harm, nor any adverse event, due to the reported issue.Investigation summary: review of the cns and gz's logs, a definitive root cause for this issue could not be determined.Although, the logs show the patient was discharged by the customer this does not explain the screen being locked, as the customer claims.This could potentially be due to user related mishap.The screen could have not been locked when the patient was discharged, clinical staff member could have unlocked the screen to enable the discharge option or not following proper workflow of the hospital could have caused the accidental discharge of the patient.Nkc recommended upgrading the customer's software revision to give visibility of the admit/discharge function.Following the proper cns operators manual for the admit/discharge function may prevent future issues with admitting or discharging a patient.Countermeasures to prevent reoccurrence a design change that was implemented to add a function which enables the history of the admit/discharge function on the gz's window.Nihon kohden corporation advised the customer to upgrade to the latest version of gz software so history of admit/discharge functions can be documented.Device history: a serial number review of the reported device (pu-681ra, serial number 1447) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.Customer provided the concomitant medical device involved but did not provide the patient information above.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: vital sign telemeter: model #: gz-130p serial #: (b)(6) device manufacturer data: 06/23/2020 unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that at the central nurse's station (cns) a patient had been discharged and they lost visibility of the patients' demographics on the cns.The bme stated the issue was resolved because they noticed the patient was discharged and that is what caused the demographics to be lost at the cns.The bme stated he had screen lock on but when he checked out the device it was unlocked.The bme stated he also noticed a red circle next to a triangle with closed parenthesis.No patient harm was reported.The bme requested nihon kohden to investigate what caused the patient to be discharged as the monitor technicians are stating that they did not discharge the patient.The bme sent in the event logs to nihon kohden for further investigation.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17553422
• MDR Text Key: 321754058
• Report Number: 8030229-2023-03708
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: VITAL SIGN TELEMETER (GZ); VITAL SIGN TELEMETER (GZ)