RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Improper Flow or Infusion (2954)
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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) 2020.Date of report: 21apr2020.
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Event Description
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The customer reported constant output flow when o2 is connected, even when it shouldn't.The customer contacted product support and was advised to replace the o2 valve.Product support provided the part number.The customer reported that the unit was in use on a patient, but there was no patient harm reported.
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Manufacturer Narrative
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G4: 04may2020; b4: 15jun2020.The biomedical engineer states that unit was not in use on patient.The biomedical engineer replaced the solenoid valve to address the reported issue.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: 30apr2020.B4: 05may2020.H10: d4: serial number: (b)(6).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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