RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
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: 22jul2020.
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Event Description
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The customer reported receiving an alarm light emitting diode (led) alert during the power on self test.There was no patient involvement.The manufacturer's field service engineer (fse) provided remote support and advised to replace the power switch overlay.
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Manufacturer Narrative
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Date received by manufacturer: 08oct2020, date of this report: 09oct2020.Customer reports the issue was resolved by replacing the power switch overlay, user interface and user interface cable.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: 12oct2020.B4: 13oct2020.The issue was discovered during preventative maintenance.There is no potential for patient harm so this complaint is not reportable.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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