Model Number 27053 |
Device Problems
Failure of Device to Self-Test (2937); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The astral device was returned to resmed.The investigation methods, results and conclusion are not finalized at this stage.If more information becomes available, a supplementary report will be submitted.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 error message (sf142) related to the software.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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Visual inspection revealed contamination within the pneumatic block.The pneumatic block 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 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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During evaluation, an astral device failed to complete its service 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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