RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Tidal Volume Fluctuations (1634); Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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: 15oct2019.The service technician verified the reported problem.The service technician replaced the gas delivery system (gds) and filter to address the reported problem.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is not a relationship of the device to the reported problem.No parts were returned for failure investigation, therefore the root cause at the component level could not be determined.
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Event Description
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During servicing of this unit the customer reported to the service technician that the tidal volume is too low and the fan filter is missing.The customer reported that the unit was not in use on patient.
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Manufacturer Narrative
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Date received by manufacturer: 27mar2019.Date of report: 15oct2019.Device code added.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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Search Alerts/Recalls
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