MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problems Loss of Power (1475); Device Operational Issue (2914)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) was randomly shutting down.No patient harm was reported.They were provided with the part number for a new power supply to resolve the issue.

Event Description

The customer reported that the central nurse's station (cns) was randomly shutting down.

Event Description

The customer reported that the central nurse's station (cns) was randomly shutting down.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2017, (b)(6) reported the cns-9701a (pu-971ra sn:(b)(6) ) shuts down randomly.Service requested troubleshooting/assistance.Service performed customer found the power supply unit was bad on the cns.Part information provided: 635689 - power supply unit, mu-971r customer ordered power supply from customer service and no longer wished to send the unit in for repair.Investigation result the cns was put into service on 06/04/06, which is over 11 years prior to the reported issue.A review of cns service history found no previously reported issues with the unit or servicing performed.There was a failure of the power supply unit #(b)(6).Per cns-9701a service manual rev.E, customer is advised to perform maintenance check on the unit once every six months.This includes checking the physical condition of each unit and its peripheral accessories, along with checking the operation of the unit.Information on if this was regularly performed is unknown.Troubleshooting of the cns and replacement of the power supply unit is also addressed in the cns-9701a service manual.The power supply unit is a supporting accessory not a patient monitoring device.As the cns/power supply unit was not returned, nka evaluation could not be performed.The condition of the power supply is unknown.If the customer had not replaced the power supply unit during the lifetime of the cns, this would indicate the part was over 11 years of age at the time of failure.During this time, factors such as use, power issues, and other environmental factors at the facility could contribute to degradation of the part.Customer was able to resolve the issue by purchasing a new power supply.There were no further reported issues with the cns's power supply.Based on the given information, this issue is not suspected to be caused by deficient design.Corrected information: g4.Date received by manufacturer: should be 12/14/2017 not 01/16/2018 as listed on mdr initial report.

• Brand Name: CNS-9700A
• 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: 7199687
• MDR Text Key: 97670746
• Report Number: 8030229-2018-00011
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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-9700A
• Device Catalogue Number: MU-971RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Distributor Facility Aware Date: 07/10/2019
• Device Age: 141 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1