RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Increase in Pressure (1491); Device Displays Incorrect Message (2591)
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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) 2020.Date of report: 21sep2020.
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Event Description
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It was reported that the ventilator had an error code indicating pressure regulation high.There was no patient involvement.The customer troubleshot with technical support and was advised to perform a performance verification testing (pvt).
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Manufacturer Narrative
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G4: 04nov2020.B4: (b)(6) 2020.The customer reported that a flow sensor and data acquisition board were ordered and were received.Multiple attempts were made to obtain information on the repair/service of the device that have been unsuccessful.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: 04nov2020 b4: (b)(6) 2020 upon a follow up, the customer had reported to technical support that a flow sensor and data acquisition board were ordered and were received.Multiple attempts were made to obtain information on the repair/service of the device that have been unsuccessful.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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