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

Model Number CNS-6801A

Device Problems Application Program Problem (2880); Unintended Application Program Shut Down (4032)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device information: 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 the mouse was lagging on the central nurse's station (cns), and then the cns rebooted by itself.Then all the tiles came up blank as if no beds were assigned to the cns.They said that the mouse was showing a trace when he moved it around.Tech support (ts) had the biomed restart the cns, but the issue remained.Then tech support had them reboot the kvm, both receiver and sender and the issue remained.At this point, tech support let them know that it seems to be either the sender and the receiver because they are getting video distortion on one of the displays.They checked the connections on the kvm, and they are all good.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
• MDR Report Key: 13120153
• MDR Text Key: 285734287
• Report Number: 2080783-2021-02231
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/30/2021

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: 12/30/2021
• Distributor Facility Aware Date: 12/01/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1