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

Model Number CNS-6201A

Device Problem Electrical Power Problem (2925)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.The cns is currently plugged into an outlet.The customer is requesting the ups part number and it was provided.The customer was then transferred to customer service for pricing on the part.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 uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.Reported.

Event Description

The customer reported that the uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.Reported.

Manufacturer Narrative

Details of complaint: the customer reported that the uninterruptible power supply (ups) associated with this central nurse's station (cns) is currently no longer functioning.The unit is unable to power on when connected to the ups.The cns is currently plugged into an outlet.The customer is requesting the ups part number and it was provided.The customer was then transferred to customer service for pricing on the part.There was no patient injury reported.Investigation summary: the cns shut down due to a bad ups battery.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.

• 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: 12132589
• MDR Text Key: 281102543
• Report Number: 8030229-2021-00395
• 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

• 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
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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