RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900T11C |
Device Problem
Degraded (1153)
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Patient Problems
Unspecified Kidney or Urinary Problem (4503); Solid Tumour (4552)
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Event Date 04/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned to manufacturer.
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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 manufacturer received information alleging growth on thyroid and kidney.The patient also alleges mold in device.Medical intervention was not specified.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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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 manufacturer received information alleging growth on thyroid and kidney.The patient also alleges mold in device.Medical intervention was not specified.Additional information received from the patient indicates that biopsy on thyroid was benign and will be checked annually.Kidney growth is also being monitored, but biopsy has been not done yet.
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Search Alerts/Recalls
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