Model Number 27093 |
Device Problems
Mechanical Problem (1384); Poor Quality Image (1408); Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed for an extensive 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 stopped ventilation and had a black screen.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 stopped ventilation and had a black screen.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.Review of the device data logs revealed multiple safety reset alarms.Performance testing confirmed the reported complaint.Visual inspection of the device revealed an electrical signal contact pin between the internal battery¿s terminal to the main circuit board was defective.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 main circuit board.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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