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

Model Number CNS-6201

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) failed while monitoring patients.The cns was connected to an ups that failed and caused the cns to go down.The cns was then plugged directly into a wall jack and was up and running.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 while monitoring patients.The cns was connected to an ups that failed and caused the cns to go down.The cns was then plugged directly into a wall jack and was up and running.No patient harm reported.

Event Description

The customer reported that the central nurse's station (cns) failed while monitoring patients.The cns was connected to an ups that failed and caused the cns to go down.The cns was then plugged directly into a wall jack and was up and running.No patient harm reported.

Manufacturer Narrative

Complaint information: on (b)(6) 2019, customer at (b)(6) health services reported ups was no longer functioning with ups part # abce350-11iec.Details of cns device connected with the issue have not been reported at the time of complaint, such reports are addressed under capa-18-033.Service requested: assistance in troubleshooting service performed: customer reported that the ups was no longer functioning.This caused the cns connected to it went down for a brief amount of time.Cns was later connected to now connected to the wall outlet and was functioning as per nk specifications.Cns was down for a very short time span.Customer also reported that re-setting ups and unplugging / re plugging also did not help in bringing ups functioning.Investigation result: nature of complaint: ups failure.Complaint pattern: review of device history found no similar incidents on ups failure review of customer's account found one similar incident on ups failure in tickets (b)(4) reported on 03/25/2018, when customer reported about out of box failure of ups.Since the details of cns i.E.Product family and serial # could not be duplicated, the review of device family history could not be reviewed.Root cause analysis method and result: root cause analysis method used in this complaint is: [?] fish bone or cause and effect or ishikawa diagram for ups failure, to identify possible causes for failure of ups: machine: o inherent limitations e.G.Single device connection, limited battery capacity, etc.Material: o condition of ups outlet o condition of connected cables o battery needing replacement.Environment: o location of ups o frequency of power outage o uncertain duration of power outage o wall condition or ac outlet.Person: o lack of user education on limitations of ups o communication gap on maintenance between nk and vendor o user error of frequent disconnection of ups from ac power.Method: o manual requirement o using power strip or extension cords o process of usage by user o lack of maintenance.The root cause of the result: root cause of ups failure could not be identified; however, possible cause of ups failure has been listed above as a part of ishikawa/ fishbone / cause and effect diagram.Ups is outsourced from ametek powervar, which is not a part of nk devices.Per manufacturer's manual, the batteries are designed to last from 2-5 years, but their actual life span will depend on several factors including how often power outages occur, how long power outages last, and the temperature of the environment in which the ups operates.The ups is intended to be used as a back-up power source in case ac power was lost and is not meant to be used as a stand-alone power supply.Risk assessment: as documented in the quality complaint investigations work instruction, with document id: sop06-075.Severity of the issue: moderate.O rationale: the risks of cns device being off due to power issue resulting from ups failure is that there is a loss of central monitoring of patient's vital signs and waveforms, along with other patient information.The cns monitors both bedside and wireless telemetry transmitters devices.Bedside monitors have local alarm functions, both audible and visual, while wireless telemetry transmitters display compressed waveform and numeric data of the latest 10 minutes.When the cns is powered off, the issue is immediately noticeable by the attending clinician.If alternate monitoring means are not available for the wireless telemetry patients, there is a possible loss of patient monitoring.Probability of the issue: unlikely o rationale: the probability of this issue re-occurring is derived from c4c data.Data was pulled on (b)(6) 2020.Out of 33046 records, the ticket title is filtered for "ups" keyword.User education has been opted out from service and incident categories.File status is filtered out void cases.The model is filtered to show only "pu-621ra" incidents.(b)(4).According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: medium.Investigation conclusion: root cause of ups failure could not be identified; however, possible cause of ups failure has been listed above as a part of ishikawa/ fishbone / cause and effect diagram.According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: medium.Corrected information: g4.Date received by manufacturer: should be 03/29/2019 not 04/26/2019 as listed on mdr initial report.

• 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: 8557850
• MDR Text Key: 143447156
• Report Number: 8030229-2019-00123
• 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: 01/30/2020

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-6201
• Device Catalogue Number: PU-681RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2020
• Distributor Facility Aware Date: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1