Model Number 27003 |
Device Problem
Operating System Becomes Nonfunctional (2996)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).
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Event Description
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It was reported to resmed that an astral device had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
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Manufacturer Narrative
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The astral device was not returned to resmed.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a device specification limitation.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
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Event Description
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It was reported to resmed that an astral device had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
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Search Alerts/Recalls
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