Model Number 27063 |
Device Problems
Failure to Calibrate (2440); Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The astral device was returned to resmed.Evaluation confirmed the reported complaint.The pneumatic block was replaced to address the 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 contamination.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 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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