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

Model Number CNS-6801A

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse station (cns) screen seemed to be frozen and was not reacting to the touch or movement of the mouse even though they were able to see patients on the screen.No patient harm was 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.Attempt #1: on 08/23/2021: emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: on 08/24/2021: emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the central nurse station (cns) screen seemed to be frozen and was not reacting to the touch or movement of the mouse even though they were able to see patients on the screen.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the screen on the central nurse station (cns) seemed to be frozen and was not reacting to touch inputs or movement of the mouse.They were able to see patients on the screen.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the screen on the central nurse station (cns) seemed to be frozen and was not reacting to touch inputs or movement of the mouse.They were able to see patients on the screen.No patient harm was reported.Investigation summary: as the reported device was not returned for evaluation, the issue of frozen cns could not be confirmed or duplicated.As such a root cause cannot be determined.A frozen cns may be a result of hardware failure.Spontaneous shutdown or spontaneous reboot events are triggered by either a power loss or a hardware failure.The causes of each are discussed below.Power loss: when the cns experiences a power loss, it can be caused by a variety of events.These events include power outages, generator tests, ups failure, power outlet failure.These are environmental factors that impact device functionality.Hardware failure: hardware failure that may result in a spontaneous shutdown or reboot includes power cord failure, a hard drive failure, and various other essential components of a computer system such as the cooling fan, internal power supply, motherboard, cpu, memory, etc.Most commonly, hard drive failures will result in a spontaneous shutdown or reboot.Causes of hard drive failures include normal hard drive failure or failure resulting from frequent power loss, or inappropriate shutdown/reboot procedure.The operator's manual outlines specific steps to perform a device shutdown or reboot.As with any device, the hard drive supplied with the cns has limited durability.It is the manufacturer's recommendation to have hard drives replaced every two years or 20,000 hours of use.As a maintenance reminder, the user is prompted with a message on the bottom right of the cns screen to check the hard drive status once usage has reached 20,000 hours.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal complaint reporting of similar events.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12363530
• MDR Text Key: 268064104
• Report Number: 8030229-2021-01550
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/01/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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