Model Number 36351 |
Device Problems
Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Low Oxygen Saturation (2477)
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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.(b)(4).
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Event Description
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It was reported to resmed that a patient had an oxygen desaturation and the s9 autoset cs-a device was found by the nurse to be stopped while in use on the patient and inoperable.It was reported that the patient was placed on a different device and oxygen saturation recovered.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 s9 autoset cs-a device was returned to resmed for an investigation.Performance testing confirmed the reported complaint.Disassembly and visual inspection of the device revealed evidence of water ingress.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to water ingress of the device main pcba.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 a patient had an oxygen desaturation and the s9 autoset cs-a device was found by the nurse to be stopped while in use on the patient and inoperable.It was reported that the patient was placed on a different device and oxygen saturation recovered.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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