The manufacturer received information alleging the patient the patient has been using their device for about a year in may and after surgery their o2 levels were dropping too low, even with the cpap.The patient's physician order another sleep study which found that the patient needed high pressure to keep their o2 levels up.The first night with their machine the new pressure the patient's lips were blowing open and their mouth got dry.They switched masks and was awoken by the leaks.The mask rubbed the bottom of their nose raw.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.
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The manufacturer previously reported and event alleging the patient the patient has been using their device for about a year in may and after surgery their o2 levels were dropping too low, even with the cpap.The patient's physician order another sleep study which found that the patient needed high pressure to keep their o2 levels up.The first night with their machine the new pressure the patient's lips were blowing open and their mouth got dry.They switched masks and was awoken by the leaks.The mask rubbed the bottom of their nose raw.The previous report incorrectly captured the reported event as an adverse event, required intervention as outcomes attributed to ae and type of reported complaint as serious injury.The event is a product problem.The form's box b: adverse event or product problem and box h: device manufacturers have been updated.
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