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

Model Number CNS-6201A

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

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

The customer removed the ups from service and replaced it with a ups model that is not nka approved, which could cause liability issues.Technical support (ts) advised the customer to purchase a new ups.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 uninterruptible power supply (ups) that the central nurse's station (cns) is connected to failed and the cns shut down.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the uninterruptible power supply (ups) that the central nurse's station (cns) is connected to failed and the cns shut down.The customer removed the ups from service and replaced it with a ups model that is not nka approved, which could cause liability issues.Technical support (ts) advised the customer to purchase a new ups.There was no patient injury reported.Investigation summary: the cns shut down due to a bad ups battery.The reported issue does not require further investigation through capa process as the issue was caused due to the failure of a non-nk manufactured accessory device and not nk device malfunction / deficiency.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that the uninterruptible power supply (ups) that the central nurse's station (cns) is connected to failed and the cns shut down.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: 13011640
• MDR Text Key: 285067043
• Report Number: 8030229-2021-02117
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• 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