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

Model Number CNS-6801A

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

According to the customer, the uninterruptible power supply (ups) is no longer working; therefore, the ups stopped providing power to the cns, which caused the cns to turn off.The ups is being exchanged.

Event Description

The customer reported that the central nurse's station (cns) turned off.There was no patient injury 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: 13253028
• MDR Text Key: 286953271
• Report Number: 2080783-2022-02331
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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: 01/13/2022
• Distributor Facility Aware Date: 12/15/2021
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1