Model Number 27053 |
Device Problems
Premature Discharge of Battery (1057); Failure to Charge (1085); Failure to Power Up (1476)
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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 and an evaluation confirmed the complaint.The internal battery was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).
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Event Description
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It was reported to resmed that an astral device failed to charge its internal battery and had an internal battery with a reduced level of capacity.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.Review of the device data logs confirmed the reported complaint and revealed an external battery communications lost alarm.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the device failure to start up and external battery communications lost alarm were due to a software issue; the sf180 was due to device operation in a temperature outside of the device specification and the failure to charge its internal battery was due to operator error.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 failed to start up, charge its internal battery and had an internal battery with a reduced level of capacity.It was reported during evaluation of the device by resmed, the astral device displayed an error message (sf180) related to a battery charger fault.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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