Catalog Number 001210 |
Device Problem
No Flow (2991)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 08/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.Due to device unavailability, no further evaluation can be completed a this time.
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Event Description
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It was reported to vyaire that the oxygen reservoir bag did not inflate properly.The customer reported potential patient harm associated with the reported issue.The patient "desated" and was unable to complete his regular 6 minute walk.The reported malfunction caused the patients saturation to drop to 61%.No further harm was noted.
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Manufacturer Narrative
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Correction: was not initially selected from the previous medwatch report.Corrected vyaire's manufacturer address.Results of investigation: one sample was received by vyaire medical quality team for further investigation.Upon investigation, it has been identified the assembly method of the gaskets is not clearly defined during the manufacturing process.This issue will be internally investigated within vyaire.
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Event Description
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Oxygen reservoir bag does not inflate properly.Disks over vents appear to be to rigid which does not allow for expiration.One way valve does not allow for oxygen to be breathed in from the reservoir bag and bag does not move even when used on a healthy person.The issue caused a pulmonary fibrosis patient awaiting lung transplant to desaturate to 61% on his regular 6 minute walk.The patient was brought back to a chair and began to recover.However, after eight minutes of recovery the saturation was still low at 70%.Activity was seized and patient put onto regular manufacturer's mask.
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Search Alerts/Recalls
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