Model Number 27072 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2020 |
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.When more information is 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 displayed an error message (sf108) related to pressure measurement.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 (sf108) related to pressure measurement.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 could not reproduce 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 operator error.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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