Model Number 27074 |
Device Problems
False Alarm (1013); Battery Problem (2885); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is currently being returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental 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 displayed a battery error message and an error message (sf131) related to the main blower temperature sensor.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.Review of the device data logs confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue.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 displayed an error message (sf131) related to the main blower temperature sensor.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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