MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) was not booting up after a power outage.The customer also reported that after the power outage their generator never kicked in so the uninterruptible power supply (ups) rebooted which caused the cns to go down.Nk ts advised the customer to remove hdd1 and boot hdd2 in hdd1 location, which resolved the issue.The customer will receive a replacement hdd.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 central nurse's station (cns) was not booting up after a power outage.

Manufacturer Narrative

Details of complaint: on 10/24/2019 customer stated that a power outage caused the cns device to lose power and shut down.Customer booted the device back with the spare built-in raid drive.No other issues were reported with the cns.Investigation summary: based on the information provided, the root cause of the boot up issue was due to hospital's power issue.Specifically, the power outage caused abrupt loss of power to the device, causing it to shut down.No other issues were related to this cns.Due to the issue not caused by the device and rather an environmental issue, no capa is required.Device has built in mitigation mechanisms that reduce the risks to patient harm.Please see health hazard assessment (hha 20-001.Pdf) for details.The following field contains no information (ni), as attempts to obtain information were made, but not provided: d11 & c2 concomitant medical products additional information: b4.Date of this report; 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?; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

Event Description

The customer reported that the central nurse's station (cns) was not booting up after a power outage.

• Brand Name: CNS-6801A
• 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: 9312747
• MDR Text Key: 170038700
• Report Number: 8030229-2019-00650
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Distributor Facility Aware Date: 03/03/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1