RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Self-Activation or Keying (1557); Failure to Read Input Signal (1581); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2021.Date of report: 05mar2021.
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Event Description
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The customer reported the nav ring not working when adjusting settings.The customer reported settings were automatically accepting changes and the behavior of changing and accepting was continuous.Staff was attempting to decrease o2% and it kept turning itself up to 100% and bouncing between 96%-100%.The user was not able to change the value or hit change/accept.Output did not change as delivery had not yet started.There was no patient involvement.The unit was being set up for use, but the patient was not yet on the unit.There was a slight delay in patient therapy initiation, however, there was no patient harm as a result of this delay.Staff continued set-up on a different device.The field service engineer (fse) was dispatched to the customer site for additional evaluation.The fse determined the front bezel needed to be replaced.The fse replaced the front bezel and the issue was resolved.
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Search Alerts/Recalls
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