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

Model Number CNS-6801A

Device Problem Defective Component (2292)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

The customer reported a bad hdd on this central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

The customer reported a bad hdd on this central nurse's station (cns).According to the customer, there's only one hdd with a red status light and the error code 41 being displayed.Technical support (ts) informed the customer that the hdd needs to be replaced.Ts provided the customer with the part (000063436) number for the hdd.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 3: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.B6 attempt # 1: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.B7 attempt # 1: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.D10 attempt # 1: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for (b)(6) to call me back with the patient and device information.

Manufacturer Narrative

Details of complaint: the customer reported a bad hdd on this central nurse's station (cns).According to the customer, there's only one hdd with a red status light and the error code 41 being displayed.Technical support (ts) informed the customer that the hdd needs to be replaced.Ts provided the customer with the part (000063436) number for the hdd.There was no patient injury reported.Investigation summary: the error message displayed by the cns is related to failure of the hdd.The error message would require replacement of the hdd to resolve the issue.The hdds are mechanical components that may deteriorate through time and may wear from continual use.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 04/26/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 2: 05/01/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 3 05/08/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.B6 attempt # 1: 04/26/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 2: 05/01/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 3 05/08/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.B7 attempt # 1: 04/26/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 2: 05/01/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 3 05/08/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.D10 attempt # 1: 04/26/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 2: 05/01/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Attempt # 3 05/08/2023 a phone call was made in an attempt to gather patient and device information, a voice mail message was left for james to call me back with the patient and device information.Manufacturer references (b)(4) follow up 001.

Event Description

The customer reported a bad hdd on this central nurse's station (cns).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: 16908316
• MDR Text Key: 315282748
• Report Number: 8030229-2023-03482
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: 04/11/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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