Model Number 27001 |
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 02/02/2023 |
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 additional information becomes available, a supplemental 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 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.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains 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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