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Model Number V60 |
Device Problems
Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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: 30oct2020.
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Event Description
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The customer reported multiple errors when powering on the ventilator to include 3v supply failure, 5v supply failure, 35v supply failure, 3.3v supply failed, motor controller board failure, over voltage protection circuit failed as well as the vent info screen the blower controller shows 0 hours and no part number.The device was in clinical use at the time of the issue however no patient harm was reported.The customer attempted to replace the power management board and the issue persists.
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Manufacturer Narrative
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G4:22dec2020.B4:23dec2020.H6: patient code updated: there was no patient involvement.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: 02nov2020; b4: 02nov2020.The customer replaced the motor controller board and the issue was resolved.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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