MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

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

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

The customer reported that this bedside monitor's (bsm) screen is black at all times.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this bedside monitor's (bsm) screen is black at all times.Technical support (ts) troubleshot the issue; however, the issue remained.The customer will try to repair the unit on their own.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 bedside monitor's (bsm) screen is black at all times.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this bedside monitor's (bsm) screen is black at all times.Technical support (ts) troubleshot the issue; however, the issue remained.The customer will try to repair the unit on their own.There was no patient injury reported.Investigation summary: without evaluation of the complaint device, the root cause of the issue could not be identified.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for device information: no reply was received.Manufacturer references (b)(4) follow up 001.

• Brand Name: CNS-9700A
• 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: 16808114
• MDR Text Key: 313937539
• Report Number: 8030229-2023-03497
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• 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: 07/25/2023

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-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2010
• 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