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 02/24/2023

Event Type  malfunction  

Event Description

The customer reported that a bed is missing from the first sector in the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

The customer reported that a bed is missing from the first sector in the central nurse's station (cns).According to the customer, they had to go in and reselect the bed again.The customer believes the bed was removed on its own.Per the customer, the data was still at the bedside.The customer will provide the logs to determine how the bed was removed.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 03/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/13/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have the patient information.Attempt # 1: 03/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/13/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have the patient information.Attempt # 1: 03/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/13/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have the patient information.Attempt # 1: 03/08/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 03/13/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have the patient information.

Event Description

The customer reported that a bed is missing from the first sector in the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that a bed is missing from the first sector in the central nurse's station (cns).According to the customer, they had to go in and reselect the bed again.The customer believes the bed was removed on its own.Per the customer, the data was still at the bedside.The customer will provide the logs to determine how the bed was removed.There was no patient injury reported.Investigation summary: the customer sent the logs to investigate the cause of the issue.The logs investigation was unable to identify the cause of the issue.There were logs of multiple wlan transports around the time of the reported event, however, all wlan transports were successful.The root cause of the issue could not be identified at this time.Manufacturer references # (b)(4) follow up 001.

• 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: 16824759
• MDR Text Key: 314106872
• Report Number: 8030229-2023-03433
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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: 02/24/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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