Model Number 27001 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2022 |
Event Type
malfunction
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Event Description
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It was reported to resmed that an astral device displayed an error message (sf101) related to pressure measurement.There was no patient involvement reported.
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Manufacturer Narrative
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The astral device was returned to resmed.Evaluation confirmed the reported complaint.The device was recalibrated to address the issue.The device was serviced and fully 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 displayed an error message (sf101) related to pressure measurement.There was no patient involvement reported.
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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.Visual inspection of the pneumatic block revealed contamination.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to 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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Search Alerts/Recalls
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