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Model Number V60 |
Device Problem
Defective Component (2292)
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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: 06aug2020.
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Event Description
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It was reported that the ventilator had a faulty navigation ring.There was no patient involvement.
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Manufacturer Narrative
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G4: 15sep2020.B4: 22sep2020.The service engineer (se) inspected the device.The se confirmed the reported issue.The se replaced the front bezel to address the issue.The unit was checked overall, 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: 22oct2020.B4: 23oct2020.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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Manufacturer Narrative
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G4:30mar2021 b4:(b)(6)2021 parts were received and it was identified that previous investigations have shown liquid ingress is due to the variability of the assembly process causing the reported navigation ring failure.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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