RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Loose or Intermittent Connection (1371)
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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: 08apr2020.
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Event Description
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The customer reported a loose nurse call connector.The device was not being used for treatment when the reported event occurred and there was no patient involvement.
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Manufacturer Narrative
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G4: 09apr2020.B4:10apr2020.The customer evaluated the device and confirmed the reported problem.The customer replaced the central processing unit (cpu) board and the reported problem was resolved.The ventilator was calibrated successfully and passed all required testing.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: 25jul2020.B4: 29jul2020.H6: method code updated.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: 25jul2020.B4: (b)(6)2020 a cpu (central processing unit) board was returned for analysis.A visual inspection of the returned component was performed; no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed, and the product analysis technician reported that the root cause was isolated to physical damage to the remote alarm connector (j1).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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