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

Model Number CNS-6801A

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is having spontaneous shut down on its own.Technical support (ts) suggested for the customer to isolate the cns temporarily to a different power source as it could be that the power is surging and too much items are connected to the same uninterruptible power source (ups).The customer will try this and reach out to ts if needed.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 the central nurse's station (cns) is having spontaneous shut down on its own.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) is having spontaneous shut down on its own.Technical support (ts) suggested for the customer to isolate the cns temporarily to a different power souce as it could be that the power is surging and too much items are connected to the same uninterruptible power source (ups).The customer will try this and reach out to ts if needed.There was no patient injury reported.Investigation summary: the facility experienced a power outage and their cns shut down.Why? too many devices connected to a single ups causing a power surge.Improper device setup the cause of the issue was determined to be improper device connections and setup at the user facility.Investigation determined the complaint record did not involve a failure/malfunction of the nk product.The issue was caused improper device connections and setup at the user facility.No further investigation is needed.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient information available.Attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient information available.Attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; no patient information available.Attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 10/19/2021 emailed the customer via microsoft outlook for device information: the customer replied by stating; no patient information available.Manufacturer references # (b)(4).Follow up 001.

Event Description

The customer reported that the central nurse's station (cns) is having spontaneous shut down on its own.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 ; 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: 12715405
• MDR Text Key: 279102686
• Report Number: 8030229-2021-01878
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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