Model Number 27081 |
Device Problems
Premature Discharge of Battery (1057); Failure to Charge (1085)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2020 |
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 external battery detection issue and an intermittent charging 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 could not reproduce the reported complaint.Review of the device data logs confirmed external battery disconnection alarms and revealed a defective external battery.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported external battery disconnection alarms were due to an intermittent connection with the battery while the defective external battery 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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Event Description
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It was reported to resmed that an astral device had an external battery detection issue and an intermittent charging issue.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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