Model Number 27918 |
Device Problems
Premature Discharge of Battery (1057); Power Problem (3010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed for an extensive 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 astral device had a power source detection issue.There was no patient harm or serious injury reported as a result of this incident.
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Event Description
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It was reported to resmed that an astral device had a power source detection issue.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 returned to resmed for an investigation.Performance testing reproduced the reported complaint.Review of the device data logs revealed an external battery with a reduced level of capacity.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported event was due to an isolated component failure within the device battery assembly.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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