MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Appropriate Term/Code Not Available (3191)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that when they pause a tile for the patient, if they get a bath or a test etc, when they resume again the room number goes away and they have to add again, the issue was for only the one central nursing station (cns).Other central nursing station (cns) in the room do not have this problem.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.

Event Description

The customer reported that when they pause a tile for the patient, if they get a bath or a test etc, when they resume again the room number goes away and they have to add again, the issue was for only the one central nursing station (cns).Other central nursing station (cns) in the room do not have this problem.No patient harm was reported.

Event Description

The customer reported that when they pause a tile on the central nursing station (cns), the room number would disappear when monitoring was resumed.They then would need to add the device back to the cns.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that when they pause a tile on the central nursing station (cns), the room number would disappear when monitoring was resumed.They then would need to add the device back to the cns.No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) recommended the customer restart the cns.Three (3) attempts were made to collect additional information from the customer.However, no response was received.A review of the history of the serial number identified no further reports of the issue, suggesting that the issue may have been resolved.Based on the available information, a definitive root cause could not be identified.A possible cause of the issue is long uptime/runtime of the device without a restart.Long uptime of the device without a restart may cause the cns operation to become unstable and may stop monitoring.It is recommended in the operator's manual of the device to reboot the cns once every three months.

• Brand Name: CNS-6201A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11127938
• MDR Text Key: 226265830
• Report Number: 8030229-2021-00001
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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