Model Number 36125 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Type
Injury
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Manufacturer Narrative
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Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.(b)(4).
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Event Description
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It was reported to resmed that a patient's oxygen saturation decreases to 84% during use of an s9 autoset device with supplemental oxygen.It was reported the patient's oxygen saturation did not decrease when placed on supplemental oxygen without the device.
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Manufacturer Narrative
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The s9 autoset device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.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's oxygen saturation decreases to 84% during use of an s9 autoset device with supplemental oxygen.It was reported the patient's oxygen saturation did not decrease when placed on supplemental oxygen without the device.
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Search Alerts/Recalls
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