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

Model Number CNS-6201A

Device Problems Overheating of Device (1437); Loss of Power (1475); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) application spontaneously shut down and that the power supply to the cpu burned up, causing an interruption in patient monitoring.Nk ts agent advised the customer to replace the power supply unit inside the cns tower.The customer reported that this resolved the issue and that their cns is functioning as intended.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 when additional information becomes available.The following field contains no information (ni), as attempts to obtain information were made, but not provided: attempts to obtain information on the devices that were monitoring patients at the time of the failure were made, but not provided.

Event Description

The biomedical engineer reported that the central nurse's station (cns) application spontaneously shut down and that the power supply to the cpu burned up.

Event Description

The biomedical engineer reported that the central nurse's station (cns) application spontaneously shut down and that the power supply to the cpu burned up.

Manufacturer Narrative

Details of the complaint on 08/10/19, customer at barnabas health reported the power supply to the cpu of the cns-6201a (pu-621ra sn: (b)(4) burned up.The cns was down and would not power back up.Service requested troubleshooting/assistance service performed customer was able to resolve the issue by replacing the power supply unit inside the cns tower.The cns was then able to power on and function correctly.Investigation result the cns warranty began 10/23/16.The issue was reported after approximately 3 years at customer facility.Review of device sap history found no previously reported issues relating to power supply.Notification 300180787 reported 20 days later indicate that the cns (sn: (b)(4).Had a lot of dust collected which caused the system to overheat and fail.The cns-6201a service manual revision g recommends that regular maintenance inspections be performed every 6 months.A maintenance check sheet is provided, which includes checking the operation of the unit and status of hardware information.In particular, internal sensor's temperature and fan speed should be checked through procedures outlined on section 5.12 of the service manual.This inspection would show the information which would prompt user to perform needed maintenance.The unit was not returned and no nka evaluation was performed.Customer was able to resolve the issue by performing internal replacement of the power supply unit.Unit has no prior history of issues with the power supply unit.From the information available, the root cause cannot be confirmed.Approximate age of the cns was 3 years.Unit has no adverse trend of power issues.The following field contains no information (ni), as attempts to obtain information were made, but not provided: d11 & c2: attempts to obtain information on the devices that were monitoring patients at the time of the failure were made, but not provided.Additional information: b4.Date of this report e3.Initial reporter f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? additional information device evaluation h6.Event problem and evaluation codes h10.Additional manufacturer narrative the following fields are not applicable (n/a) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 d11.F10 g6 g8 h7 h9.

• 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: 8962362
• MDR Text Key: 193638201
• Report Number: 8030229-2019-00426
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 11/11/2019

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2019
• Distributor Facility Aware Date: 11/04/2019
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 08/10/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI,; NI.