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Model Number V60 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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 can not log in.There was no patient involvement or user harm reported.
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Manufacturer Narrative
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G4: 11nov2020.B4: 06dec2020.The field service engineer (fse) could not confirm the reported failure; however, they did confirm the ventilator tidal volume is high advised the machine can be used normally after replacing the pipeline.Investigation is ongoing.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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G4:10jan2021.B4:12jan2021.The field service engineer (fse) confirm the reported failure.The fse identified the ventilator tidal volume was high.The fse replaced the pipeline (disposable test tubes) to resolve the issue.The unit was tested and it was returned to service.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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