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Model Number UFRX500S14 |
Device Problems
Degraded (1153); Insufficient Information (3190)
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Patient Problems
Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)
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Event Date 10/12/2023 |
Event Type
Injury
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Event Description
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The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient alleges nose irritation, respiratory tract irritation, kidney disease/toxicity and lung disease.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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Device not yet returned to the manufacturer.
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Manufacturer Narrative
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The manufacturer was contacted in reference to a recert dreamstation auto device.The patient alleges nose irritation, respiratory tract irritation, kidney disease/toxicity and lung disease.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The manufacturer previously reported the (device) problem code grid with incorrect coding which is corrected in the current report.Additionally, the country of occurrence has been corrected to reflect united states.
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Search Alerts/Recalls
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