Model Number 27074 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Date 09/25/2020 |
Event Type
Death
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Manufacturer Narrative
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The two devices were taken into police custody and not returned to resmed for evaluation.No further information has ben made available to resmed at this time.If more information becomes 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 a patient was found expired while using an astral device.The patient had been using two astral devices.No further information has been made available to resmed at this time.
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Manufacturer Narrative
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The astral device was returned to resmed for an investigation.Review of the available therapy data revealed the device was not in use on the day of the reported event.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that a patient was found expired while using an astral device.The patient had been using two astral devices.No further information has been made available to resmed at this time.
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Search Alerts/Recalls
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