RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Defective Alarm (1014); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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) 2020.Date of report: 20jan2021.
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Event Description
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The customer called technical support (ts), reporting that the device displayed an error message consistent with proximal pressure is not measured, and pressure-related alarms are compromised.The customer reported there was no patient involvement at the time the issue was discovered.
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Manufacturer Narrative
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G4:20mar2021.B4:02apr2021.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the gas delivery system (gds), v60 to resolve the reported issue.Unit passed required performance verification tests per philips standards and was approved for use.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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Visual inspection of the returned gas delivery system revealed no evidence of damage or contamination.Tests conducted on the returned material; the customer complaint was not verified.No fault found with the returned gas delivery system.
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Search Alerts/Recalls
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