RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Protective Measures Problem (3015)
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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: 09jul2020.
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Event Description
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The customer reported that the unit is showing the error message ¿high priority check vent: alarm led failed." the customer contacted product support and requested for service repair.The field service engineer (fse) replaced the power management board, but the unit still continue to have the same failure.The fse advised the customer to send the unit to one of philips bench repair for further troubleshooting and repair.The customer reported that the unit was not in use on a patient.
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Manufacturer Narrative
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G4: 22jul2020.B4: 30jul2020.The service technician reported that replacing the power switch overlay address the reported problem.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: 10sep2020.B4: 14sep2020.E1: institution name: ramsay health care.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: 13oct2020 b4: (b)(6) 2020 failure analysis on the returned power management (pm) board shows that the customer reported problem was not duplicated.Cycle testing did not replicate reported failure.All light emitting diode's (leds) operate normally.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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