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

Model Number CNS-6201A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) will not turn on and shut down while monitoring patients.The cns was connected to a ups during the power glitch they had and the battery in the ups failed and the cns shut down.The biomed was able to restart the cns.No patient harm was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The nurse reported that the central nurse's station (cns) will not turn on and shut down while monitoring patients.The cns was connected to a ups during the power glitch they had and the battery in the ups failed and the cns shut down.The biomed was able to restart the cns.No patient harm was reported.

Manufacturer Narrative

Complaint information: on (b)(6) 2019, customer at (b)(6) reported cns with blank display and pressing the power button does nothing on pu-621ra with serial# (b)(6).Service requested: assistance in troubleshooting.Service performed: customer reported that the ups was in battery mode, and the battery was dead.After pressing the reset button on ups, both cns and ups were working as per specification.Customer was able to boot up the cns without issues.Customer reported that the nk provided ups locked up during the power outage.Cns received software update from version 02-40 to 03-40 in july 2018.Cns was deployed at customer site on 7/24/2018.Investigation result: root cause of the ups with no power was power outrage.After resetting ups, both cns and ups worked as per specification.The warranty of cns device is valid till 03/01/2020.According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: medium corrected information: f9.Approximate age of device: incorrectly calcuated.G4.Date received by manufacturer: should be 03/18/2019 not 04/17/2019 as listed on mdr initial report.

Event Description

The nurse reported that the central nurse's station (cns) will not turn on and shut down while monitoring patients.The cns was connected to a ups during the power glitch they had and the battery in the ups failed and the cns shut down.The biomed was able to restart the cns.No patient harm was reported.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8525652
• MDR Text Key: 142354645
• Report Number: 8030229-2019-00102
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Distributor Facility Aware Date: 02/06/2020
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1