Model Number 27093 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2020 |
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 pneumatic block was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.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 complete its internal self-test.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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Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a faulty/defective non-return valve.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: pr (b)(4).
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Event Description
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It was reported to resmed that an astral device failed to complete its internal self-test.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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