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

Model Number CNS-6281

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) failed during a power outage and it was connected to a ups.The outlets and the ups have been checked and confirmed to be working.The cns was rebooted and returned to normal function.No patient harm 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 customer reported that the central nurse's station (cns) failed during a power outage and it was connected to a ups.The outlets and the ups have been checked and confirmed to be working.The cns was rebooted and returned to normal function.No patient harm reported.

Event Description

The customer reported that the central nurse's station (cns) failed during a power outage and it was connected to a ups.The outlets and the ups have been checked and confirmed to be working.The cns was rebooted and returned to normal function.No patient harm reported.

Manufacturer Narrative

H10: additional narrative: customer was concerned about the length of time it takes to for device to recover after power outages.Customer reported on (b)(6) 2019, it took 5 minutes for device to come back up after a power outage.Customer biomed and it confirmed the connected ups was working as intended.On (b)(6) 2019, customer reported another power outage took place; the cns took over three minutes to power back up.Further investigation by customer led to the conclusion that it's facility related issue.Customer contacted ups manufacturer, powervar, to inquire further.Customer also requested nk to close the ticket.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: service history for this device shows no other tickets have been created.This facility has not reported another power outage issue since (b)(6) 2019.There were no other incidents at this facility prior to this incident.Service and operator manuals for pu-681ra does not specify how long it takes for the device to boot up from a power loss.In this case, the issue was not with the device but between the facility and the uninterrupted power supply (ups).Follow up attempts were made to obtain information regarding the ups and the resolution of the issue.Customer responded on 7/2/2019 stating the issue is still on going, and the customer believe it is unrelated to nk equipment.Rather, customer believe the issue lies with the facility's electrical infrastructure.Update 7/16/2019: service history for this customer shows no other power outage events reported after 3/22/2019.Corrected information: f9.Approximate age of device: incorrectly calcuated.G4.Date received by manufacturer: should be 03/22/2019 not 04/18/2019 as listed on mdr initial report.Additional information: h2.If follow-up, what type? additional information correction.D11& c2 concomitant medical products: the ups was working in conjunction with the cns.

• Brand Name: CNS
• 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: 8530147
• MDR Text Key: 142487005
• Report Number: 8030229-2019-00109
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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-6281
• Device Catalogue Number: PU-681RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2019
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: UPS