Model Number 64101 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Dyspnea (1816)
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Event Date 12/07/2020 |
Event Type
malfunction
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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 using an airfit f30i mask could not exhale.The patient stated the product does not have exhale ports on the elbow of the mask.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 a patient using an airfit f30 mask could not exhale.The patient stated the product does not have exhale ports on the elbow of the mask.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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Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).
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Search Alerts/Recalls
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