Model Number 27083 |
Device Problems
Battery Problem (2885); Battery Problem: Low Impedance (2973)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
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.If more information becomes 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 had an external battery with a reduced level of capacity.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 had an external battery with a reduced level of capacity.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 complaint.Review of the device data logs revealed internal battery degraded warning alarms.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint 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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Search Alerts/Recalls
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