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Model Number V60 |
Device Problem
Defective Device (2588)
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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: 15oct2020.
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Event Description
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It was reported that the ventilator's navigation ring is defective.There was no patient involvement.
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Manufacturer Narrative
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G4: 13oct2020 b4: (b)(6) 2020 the service engineer (se) inspected the device.The se replaced the front bezel to address the reported issue.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.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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G4:12jan2021 b4:(b)(6) 2021 a front bezel was return for analysis.An investigation was performed to determine the cause of the liquid ingress due to variability of the assembly process.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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