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

Model Number CNS-6201A

Device Problems Device Inoperable (1663); Unexpected Shutdown (4019)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that after doing a generator test, the central nurses station (cns) powered down and did not come back up.The cns was connected to a ups, customer tried replacing the ups, however would like the unit repaired and has requested a loaner.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 after doing a generator test, the central nurses station (cns) powered down and did not come back up.

Event Description

The customer reported that after doing a generator test, the central nurses station (cns) powered down and did not come back up.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) reported the cns-6201a (pu-621ra sn:(b)(6)) would not power up after losing power.When they do a generator test, the cns powers down and does not come back, and he has to manually reboot the device.The cns was connected to a ups.Customer was to replace the ups.Service requested customer requested to have the cns sent in for repair due to not powering up after losing power.Service performed unit was not returned.Multiple attempts were made to follow up with the customer, receiving no response.Investigation result: the cns warranty began (b)(6) 2013, which is over 4.5 years prior to the reported issue.Review of device sap history shows no previously reported issues with boot up.Customer reported issue occurred after performance of generator test.During this process, it is critical for proper steps to be taken at the facility to ensure impact to the cns/patients is minimal.Powering down of the cns during the generator test suggests there was an issue with the ups involved.The ups, which is intended to protect the cns from power failures and surges, failed to provide back up power supply to the cns at the time.Information on the ups, along with its age and condition, is not available.The frequent occurrence of improper shut down of the cns is likely to contribute to corruption or degradation of the unit's software or parts.No nka evaluation was performed as unit was not returned and customer did not provide further explanation after repeated attempts at follow up.From the information available, the root cause is determined to be loss of power to the cns due to combination of generator test and failed ups.This issue is not suspected to be caused by deficiency of the cns or its design.Customer indicated he was to replace the ups.Review of device sap history found no further issues reported for the unit.Customer may have repaired the unit internally or removed the device from service.

• 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: 7562577
• MDR Text Key: 109889997
• Report Number: 8030229-2018-00190
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 09/26/2019
• Distributor Facility Aware Date: 09/19/2019
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1