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

Model Number CNS-6801A

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that while the physician was looking as the central nurse's station (cns) they had inadvertently moved tiles.Later that ed physician was looking at the cns and noted that the patient vital signs and rhythm had drastically changed.The ed physician went to the room to treat the patient and noted that the patient data on the bedside monitor did not match the data on the cns.It was then; that the staff noted that the tiles on the cns had changed spaces.They were looking at another patient.The ed department considered this a "near miss." 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.The following fields are not applicable (na) to the mdr report: lot number & expiration date.The following field contains no information (ni), as attempts to obtain information were made, but not provided.Serial number.Approximate age of device.Device manufacture date.Additional device information: concomitant medical products: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer (bme) reported that while the physician was looking as the central nurse's station (cns) they had inadvertently moved tiles.Later that ed physician was looking at the cns and noted that the patient vital signs and rhythm had drastically changed.The ed physician went to the room to treat the patient and noted that the patient data on the bedside monitor did not match the data on the cns.It was then; that the staff noted that the tiles on the cns had changed spaces.They were looking at another patient.The ed department considered this a "near miss." no patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that while the emergency department (ed) physician was looking at the central nurse's station (cns) the patient tiles had been inadvertently moved around.When that physician later looked at the cns, it was noted that the patient's vital signs and rhythm had drastically changed.The physician went to treat the patient and noted that the patient data on the bedside monitor (bsm) did not match the data on the cns.That is when the staff realized the tiles on the cns had been moved around.They were looking at a different patient.The ed department considered this a "near miss." no patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: the customer reported that they were unable to lock the bed tiles on the cns.The customer indicated they had close calls where the bed tile was inadvertently moved, and the monitoring clinician did not realize they were monitoring the incorrect patient.Being able to drag and drop bed tiles freely is a feature of the cns.At the time of reporting, disabling this feature was not yet available.In response to requests from customer to be able to lock bed tiles, disabling drag and drop bed tiles was added to the cns as option starting in cns-6201 v05-18 and cns-6801 v02-18.Based on the available information, the root cause of the issue is software limitation.The option to disable drag and drop was added to later versions of the software to address this limitation.

Event Description

The biomedical engineer (bme) reported that while the physician was looking as the central nurse's station (cns) they had inadvertently moved tiles.Later that ed physician was looking at the cns and noted that the patient vital signs and rhythm had drastically changed.The ed physician went to the room to treat the patient and noted that the patient data on the bedside monitor did not match the data on the cns.It was then; that the staff noted that the tiles on the cns had changed spaces.They were looking at another patient.The ed department considered this a "near miss." no patient harm was reported.

• 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 ; 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: 10406053
• MDR Text Key: 240348274
• Report Number: 8030229-2020-00448
• 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: 08/14/2020,01/23/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2020
• Distributor Facility Aware Date: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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