Model Number 27001 |
Device Problems
Battery Problem (2885); 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 02/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received by resmed and an evaluation confirmed the complaint.The top case was replaced to resolve 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 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 confirmed the reported unresponsive touchscreen.Review of the device data logs confirmed the reported internal battery degraded warning alarm.The top case and internal battery were replaced to address the issues.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the unresponsive touchscreen was due to physical damage while the internal battery degraded warning alarm was due to an isolated component failure within the device battery assembly.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 and displayed an internal battery degraded warning alarm.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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