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

Model Number CNS-6801A

Device Problems No Device Output (1435); Output Problem (3005); Patient Data Problem (3197)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

The nurse reported that the central nurse's station (cns) was no longer monitoring a bed, it just completely went blank and there was no communication loss reported or any other symptoms.No patient harm was reported.Nihon kohden technician advised the nurse to inform their biomedical department so that they can get behind the password to restart monitoring the bed.

Manufacturer Narrative

Event problem reported: the nurse reported that the central nurse's station (cns) was no longer monitoring a bed, it just completely went blank and there was no communication loss reported or any other symptoms.No patient harm was reported.Nihon kohden technician advised the nurse to inform their biomedical department so that they can get behind the password to restart monitoring the bed.Nihon kohden technician sent follow up e-mail to the nurse on august 28th to determine if the issue has been resolved and what their resolution was for this issue and no replies from the nurse have been received.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.

Manufacturer Narrative

Event problem: the nurse reported that the central nurse's station (cns) was no longer monitoring a bed, it just completely went blank and there was no communication loss reported or any other symptoms.No patient harm was reported.Nihon kohden technician advised the nurse to inform their biomedical department so that they can get behind the password to restart monitoring the bed.Nihon kohden technician sent a follow up e-mail to the nurse on august 28th to determine if the issue has been resolved and what their resolution was for this issue and no replies from the nurse have been received.Multiple follow-up requests were sent to the customer, but they were unresponsive.Investigation summary: a definitive root cause could not be determined since we could not confirm further troubleshooting or resolution details.Possible causes may include user error when using the wlan transport function for patient transfers, loss of network connection while using wlan transport, or loose connection of the input unit with the main unit bsm.When starting wlan transport, the customer should remove the input unit only after the bsm prompts the user to remove the input unit.The bsm operator's manual and user guides include instructions for performing patient transfers and using wlan transport.Loss of wireless network connection during transport can be due to an unstable network environment at the customer site.Loose connection of the input unit with the main unit may cause incomplete data communication to the cns.Review of the complaint device's serial number shows 2 previous occurrences were reported in which possible causes were also user error with patient transfer.These similar issues have been investigated by nihon kohden corporation who developed a countermeasure in the bsm-1700 software version 02-68 which was released on 10/06/2023.The following fields contain no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1 08/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/15/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/18/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.B6 & b7 attempt #1 08/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/15/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/18/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.D10 attempt #1 08/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/15/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/18/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The nurse reported that the central nurse's station (cns) was no longer monitoring a bed, it just completely went blank and there was no communication loss reported or any other symptoms.No patient harm was reported.Nihon kohden technician advised the nurse to inform their biomedical department so that they can get behind the password to restart monitoring the bed.

• 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: 17765788
• MDR Text Key: 324161617
• Report Number: 8030229-2023-03783
• 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: 12/20/2023

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: 08/25/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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: NI.; NI.