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 making rounds at hospital, the nurses in critical care told the cno that the patient tiles on the central nurse's station (cns) screen move with very little effort and no notification that the tiles moved / changed position.The cno contacted the executive director, clinical / biomedical engineering and alerted them that this was a patient safety concern that needed to be addressed with the nihon kohden.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 field contains no information (ni), as attempts to obtain information were made, but not provided.Serial number.Approximate age of device.Device manufacture date.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 making rounds at hospital, the nurses in critical care told the cno that the patient tiles on the central nurse's station (cns) screen move with very little effort and no notification that the tiles moved / changed position.The cno contacted the executive director, clinical / biomedical engineering and alerted them that this was a patient safety concern that needed to be addressed with the nihon kohden.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that while making rounds at hospital, the nurses in critical care told the cno that the patient tiles on the central nurse's station (cns) screen move with very little effort and no notification that the tiles moved / changed position.The cno contacted the executive director, clinical / biomedical engineering and alerted them that this was a patient safety concern that needed to be addressed with the nihon kohden.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that while making rounds at the hospital, the nurses in critical care advised the cno that patient tiles on the central nurse's station (cns) moved with very little effort, with no notification that the tiles were moved or had changed position.Because this was considered a patient safety concern by the hospital's executive staff, it was reported to nihon kohden.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.

• 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: 10406139
• MDR Text Key: 204194508
• Report Number: 8030229-2020-00450
• 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