Model Number 27081 |
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 05/23/2022 |
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 centre.Evaluation confirmed the reported complaint.The pneumatic block assembly 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 displayed an error message (sf188) indicating a safety assert system fault.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 astral device was returned to resmed for an investigation.Performance testing confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the 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 displayed an error message (sf188) indicating a safety assert system fault.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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