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

Model Number CNS-6801A

Device Problem Power Problem (3010)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

The customer reported that their central nurse's station (cns) experienced hdd failure and that they need to purchase new ones in order to mitigate this issue.No hard or injury 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: 12879543
• MDR Text Key: 285682579
• Report Number: 2080783-2021-02010
• 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: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• 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: 11/26/2021
• Distributor Facility Aware Date: 10/28/2021
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1