Model Number 27001 |
Device Problems
Inadequate User Interface (2958); No Tactile Prompts/Feedback (4024)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Event Description
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It was reported to resmed that an astral device had an unresponsive touchscreen.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.Evaluation confirmed the reported complaint.The top case 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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Manufacturer Narrative
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Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to physical damage.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 had an unresponsive touchscreen.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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