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

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is no longer booting up and going into windows.The unit tries to start up through bios, but then it shuts down.The customer will be sending in the device for evaluation/repair and has requested a loaner.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.Attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The customer reported that the central nurse's station (cns) is no longer booting up and going into windows.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) is no longer booting up and going into windows.The unit tries to start up through bios, but then it shuts down.The customer will be sending in the device for evaluation/repair and has requested a loaner.There was no patient injury reported.Investigation summary: the root cause of the issue is considered to be hard drive failure due to lack of preventative maintenance.Investigation of the reported issue found the root cause of the issue to be due to overdue maintenance.Hard drives are routine service component, it is expected to be replaced periodically or as indicated (preventative maintenance).This does not suggest nk device deficiency/malfunction.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2021 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: (b)(6)/2021 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: (b)(6)2021 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 (b)(6)2021 emailed the customer via microsoft outlook for device information: no reply was received.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 # 300269970 - 120252 follow up 001.

Event Description

The customer reported that the central nurse's station (cns) is no longer booting up and going into windows.There was no patient injury reported.

• Brand Name: CNS-6201A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12698834
• MDR Text Key: 278400499
• Report Number: 8030229-2021-01853
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• 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