RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
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: 25nov2020.
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Event Description
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It was reported to philips that the device had a watchdog test failure.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
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Manufacturer Narrative
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G4:28jan2021.B4:30jan2021.The device had just arrived back from bench repair for the same reported problem when the customer identified that the issue persisted.The device was sent back to philips bench repair.The bench technician performed an evaluation, and the reported issue was confirmed and traced to a faulty flow sensor.The bench technician replaced the flow sensor to resolve the issue and bring the device back to functionality.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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Gas delivery system (gds) was returned for failure investigation (fi).The fi was unable to verify the customer complaint.The returned gds was observed during a testing time of approximately one hour, during which time no alarms occurred.The returned gds passed all fi testing, and no-fault was found.
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Search Alerts/Recalls
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