Model Number 27063 |
Device Problems
Inadequate User Interface (2958); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).Device received; evaluation pending.
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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 for an investigation.Performance testing reproduced the reported complaint.The top case was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.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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