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Complaint information: on (b)(6) 2019, customer at (b)(6) reported ups failure connected to pu-621ra with serial# (b)(6) service requested: assistance in troubleshooting service performed: customer reported that their ups failed after a power outage.After a power outage/surge, the nursing staff found that two other cns had just shutdown.Nkts tried to reach out to the customer for further information, however the customer stopped communicating.After multiple attempts, customer replied with one word that the issue was resolved internally, however no further details have been provided by the customer on resolution of the ticket.Customer again stopped communicating after multiple attempts.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 no similar incidents on ups failure review of device family history pu-621ra, found following 39 similar reported complaints related to ups failure: ticket#: (b)(4) with notification # 300185817 : on (b)(6) 2019 customer at (b)(6) medical center reported issue of ups for central nursing station went down causing cns to pow on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300182459 : on (b)(6) 2019 customer at (b)(6) health attn: accounts payable reported issue of ups failed on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket#: (b)(4) with notification # 300181180 : on (b)(6) 2019 customer at (b)(6) memorial hospital reported issue of ups issue 300181180 on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300175785 : on (b)(6) 2019 customer at (b)(6) health system attn: accounts payable reported issue of pu-621ra ups failure (trb) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300175275 : on (b)(6) 2019 customer at (b)(6) reported issue of ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300172207 : on (b)(6) 2019 customer at (b)(6) hospital reported issue of pu-621ra ups failure (trb) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300168903 : on (b)(6) 2019 customer at union general hospital reported issue of pu-621ra ups failed (trb) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300165465 : on (b)(6) 2019 customer at (b)(6) memorial hospital reported issue of ups will not power on on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300164075 : on (b)(6) 2019 customer at (b)(6) attn: accounts payable reported issue of pu-621ra ups failure (trb) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300160590 : on (b)(6) 2019 customer at (b)(6) health attn: accounts payable reported issue of pu-621ra failed ups (exc) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300157721 : on (b)(6) 2019 customer at (b)(6) memorial hospital reported issue of ups failure - pu-621ra - s/n: (b)(6) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300155076 : on (b)(6) 2019 customer at (b)(6) memorial hospital reported issue of ups failed again on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300154677 : on (b)(6) 2018 customer at (b)(6) medical ctr reported issue of ups issue on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300153213 : on (b)(6) 2018 customer at (b)(6) memorial hospital reported issue of cns lost power - ups failure - cns-6201 - s/n: (b)(6) on pu-621ra with serial# 1113 the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300151443 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of failed ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300148969 : on (b)(6) 2018 customer at (b)(6) reported issue of failed ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300142457 : on (b)(6) 2018 customer at (b)(6) hospital, inc.Reported issue of ups failed due to multiple power outages on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300142117 : on (b)(6) 2018 customer at (b)(6) hospital, inc.Reported issue of pu-621ra ups is out (trb) on pu-621ra with serial#: no serial the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300140978 : on (b)(6) 2018 customer at montrose memorial hospital reported issue of pu-621ra ups is out (exc) on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300136968 : on (b)(6) 2018 customer at (b)(6) medical center reported issue of ups failure on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300136264 : on (b)(6) 2018 customer at (b)(6) memorial hospital reported issue of obf ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300135198 : on (b)(6) 2018 customer at (b)(6) memorial hospital reported issue of ups issues on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300133478 : on (b)(6) 2018 customer at (b)(6) health system attn: accounts payable reported issue of ups bad on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300132991 : on (b)(6) 2018 customer at (b)(6) hospital (b)(6) reported issue of ups is not holding a charge on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300132848 : on (b)(6) 2018 customer at (b)(6) health reported issue of ups failure on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300129839 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of failed ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300128502 : on (b)(6) 2018 customer at (b)(6) med center reported issue of ups failed on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300128277 : on (b)(6) 2018 customer at (b)(6) leasing corp.Reported issue of out of box ups failure on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300127945 : on (b)(6) 2018 customer at (b)(6) med center reported issue of ups will not power on on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300126516 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of ups failure on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300124014 : on (b)(6) 2018 customer at (b)(6) center reported issue of ups exchange on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300123638 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of bad ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300121098 : on (b)(6) 2018 customer at (b)(6).Reported issue of failed ups on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure · ticket#: (b)(4) with notification # 300120764 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of ups power issues on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300153807 : on (b)(6) 2018 customer at (b)(6) hospital reported issue of cns shut down due to a ups failure on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300154299 : on (b)(6) 2018 customer at (b)(6) med center reported issue of ups failed and the cns powered off on pu-621ra with serial# the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300163994 : on (b)(6) 2019 customer at (b)(6) health attn: accounts payable reported issue of ups failed and the cns powered off on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure ticket# (b)(4) with notification # 300125188 : on (b)(6) 2019 customer at (b)(6) med ctr reported issue of ups failed on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure.Ticket# (b)(4) with notification # 300151886 : on (b)(6) 2018 customer at (b)(6) health center reported issue of ups failed and the cns powered off on pu-621ra with serial#: (b)(6) the root cause of the issue was determined to be ups failure 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.Result: the root cause of the ups failure due to power outage 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, etc.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: (b)(4), 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 jan 22, 2020.Out of (b)(4) 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.The final result shows 39 incidents where ups caused cns, pu-621ra caused power issues.Total number of ups sold till jan 22, 2020 is (b)(4) in the us since 2014 the power issue has a rate of occurrence at 1.74%.According to the table in quality complaint investigations work instruction, with document id: (b)(4), the risk priority of the issue is categorized as: medium investigation conclusion: the root cause of the ups failure due to power outage could not be identified; however, possible cause of ups failure has been listed above as a part of ishikawa/ fishbone / cause and effect diagram.Warranty of cns device is valid till 02/29/2020.According to the table in quality complaint investigations work instruction, with document id: (b)(4), the risk priority of the issue is categorized as: medium.Investigation conclusion: the root cause of the ups failure due to power outage could not be identified; however, possible cause of ups failure has been listed above as a part of ishikawa/ fishbone / cause and effect diagram.Warranty of cns device is valid till 02/29/2020.According to the table in quality complaint investigations work instruction, with document id: (b)(4), the risk priority of the issue is categorized as: medium.Corrected information: f9.Approximate age of device: incorrectly "calculated".G4.Date received by manufacturer: should be 03/18/2019 not 04/17/2019 as listed on mdr initial report.
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