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 03/22/2023

Event Type  malfunction  

Event Description

The customer reported that this central nurse's station is frozen on a blue screen with the nihon kohden logo on it.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this central nurse's station is frozen on a blue screen with the nihon kohden logo on it.Technical support (ts) asked the customer to restart the unit, but he didn't have access to the communication closet.Ts advised the customer to contact biomed to access the communication closet and do the restart on the device.The customer will reach out again if necessary.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.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station is frozen on a blue screen with the nihon kohden logo on it.Technical support (ts) asked the customer to restart the unit, but he didn't have access to the communication closet.Ts advised the customer to contact biomed to access the communication closet and do the restart on the device.The customer will reach out again if necessary.There was no patient injury reported.Investigation summary: a definitive root cause could not be identified due to lack of information.Without a definitive root cause, countermeasures to prevent recurrence of the issue could not be identified.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that this central nurse's station is frozen on a blue screen with the nihon kohden logo on it.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
• 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: 16777436
• MDR Text Key: 313845590
• Report Number: 8030229-2023-03476
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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