Model Number 27064 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The astral device was returned to resmed and an evaluation was performed.The reported complaint could not be confirmed during evaluation.The device operated per specifications.The device was serviced, cleaned and 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 powered down during ventilation.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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During evaluation of the device, signs of physical damage and water damage were seen both internally and externally of the device.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to contamination.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 powered down during ventilation.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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