Model Number 27081 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/21/2020 |
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 batteries 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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Event Description
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It was reported to resmed that an astral device had batteries 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 device was returned to an authorized resmed third party service center 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.Based on all available evidence, an investigation determined that the reported complaint was due to a faulty/defective internal battery.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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