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Model Number V60 |
Device Problem
Device Sensing Problem (2917)
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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: 18sep2020.
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Event Description
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The customer reported unit does not recognize the blood pressure values.The device was reported to be in clinical use at the time the reported issue was discovered; however, there was no reported patient or user harm.
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Manufacturer Narrative
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G4:30dec2020.B4:31dec2020.The field service engineer (fse) indicated error code consistent with carbon dioxide (co2) leak and rebreathing and indicated the flow graph appears inverted when clicking and no volume graph appears.The fse state the unit correctly passes the "pressure delivery accuracy" test but not the "flow delivery accuracy" test, giving oscillating values without any control.Flow sensor block failure, requires gas delivery system (gds) replacement.The fse replaced the gds to resolve the reported issue.A gas delivery system (gds) was returned for analysis.Visual inspection of the returned gds revealed no anomalies.An investigation was performed and the customer complaint verified.Root cause was failure of airflow sensor, caused by u1 drifting out of calibration.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: 13nov2020 b4: (b)(6) 2020 the customer accepted the quote to replace the gas delivery system (gds).Pending for repair details.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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