RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2019.Date of report: 01/06/2020.
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Event Description
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The customer reported that the unit could not be set in standby mode.There was no patient involvement.
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Manufacturer Narrative
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G4: 27jan2020, b4: 03feb2020.The manufacturer's remote service technician performed troubleshooting with the customer.The technician recommended that the customer run performance verification testing (pvt) to isolate the issue.The customer was also provided with part information for the flow sensor assembly and data acquisition board.The customer reported that the issue had been resolved; however, no repair details were provided.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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G4 12may2020.B4: 12may2020.The gas delivery system (gds) was returned for failure analysis.A visual inspection revealed no anomalies.During testing, it was determined that the failure was caused by the u1 component drifting out of specification.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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