Model Number 27003 |
Device Problems
False Alarm (1013); Protective Measures Problem (3015)
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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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Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.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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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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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 and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue during disconnection.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
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Search Alerts/Recalls
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