Model Number 37207 |
Device Problem
Pressure Problem (3012)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported to resmed that an airsense 10 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.
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Event Description
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It was reported to resmed that an airsense 10 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.
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Manufacturer Narrative
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The astral device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
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Search Alerts/Recalls
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