Model Number 27001 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The astral device was returned to a resmed authorized third party service center.Evaluation confirmed the reported complaint.The battery was replaced to address the 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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Event Description
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It was reported to resmed that an astral device displayed an internal battery degraded warning alarm.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 displayed an internal battery degraded warning alarm.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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