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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this central nurse's station (cns) had a blue screen error message.Technical support (ts) had the customer swap the drives and the unit booted up right up into the application; however, within 2 minutes, it went back to the blue screen.The customer requested to have the hdd replaced.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 that this central nurse's station (cns) had a blue screen error message.There was no patient injury reported.

Event Description

The customer reported that this central nurse's station (cns) had a blue screen error message.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) had a blue screen error message.Technical support (ts) had the customer swap the drives and the unit booted up right up into the application; however, within 2 minutes, it went back to the blue screen.The customer requested to have the hdd replaced.There was no patient injury reported.Investigation summary: evaluation of the returned device was not able to duplicate the reported issue of watch dog violation.The reported blue screen was observed during evaluation.Replacement of one of the hdds was performed; however, though the blue screen stop occurring, the system was freezing and unresponsive.The motherboard was deemed to be defective and needed to be replaced.As such, it is likely that the unit was experiencing issues due to hardware failure of the motherboard and hdd.Manufacturer references # (b)(4) follow up 001.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18222406
• MDR Text Key: 329245580
• Report Number: 8030229-2023-03889
• Device Sequence Number: 1
• Product Code: MHX
• 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: 02/19/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• 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