Model Number 27003 |
Device Problems
Inadequate User Interface (2958); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2022 |
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 device was returned to an authorized resmed third party service center for an evaluation and service.No information is available at this time, therefore resmed is unable to confirm the alleged malfunction.Resmed reference#: (b)(4).
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Manufacturer Narrative
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The astral device was not returned to resmed.An investigation was performed on all available information.Based on all available evidence, the investigation determined that the reported complaint was due to an issue during manufacturing.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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