MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problem Loss of Power (1475)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).Technical service asked the customer to reboot the cns and once the cns application completely loaded, the customer was able to view patients, issue resolved.Ts advised the customer to restart the central monitor every three months, otherwise operation becomes unstable and monitoring may stop.There was no patient injury 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.

Event Description

The customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 11816862
• MDR Text Key: 250363079
• Report Number: 2080783-2021-00282
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• 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: 05/12/2021
• Distributor Facility Aware Date: 04/15/2021
• Device Age: 75 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1