Model Number 27918 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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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 is currently being returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.(b)(4).
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Event Description
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It was reported to resmed that an astral device had an internal battery with reduced autonomy.There was no patient 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.Review of the device data logs confirmed the reported battery autonomy issues.The external battery was replaced to address the issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the root cause was 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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Event Description
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It was reported to resmed that an astral device had an external battery with reduced autonomy.There was no patient injury reported as a result of this incident.
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Search Alerts/Recalls
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