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Model Number DSX500S11 |
Device Problem
Degraded (1153)
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Patient Problems
Unspecified Blood or Lymphatic problem (4434); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/28/2023 |
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 manufacturer received information alleging nose irritation and liver disease/toxicity.Patient reported going to a specialist and receiving medication.The patient reported he can barely walk or eat, and has excessive phlegm, bloody nose, and coughs every time he drinks water and eats.No patient information was provided.No additional information can be requested at this time.
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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Manufacturer Narrative
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The manufacturer previously reported information 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 nose irritation and liver disease/toxicity.Patient reported going to a specialist and receiving medication.The patient reported he can barely walk or eat, and has excessive phlegm, bloody nose, and coughs every time he drinks water and eats.The following sections were corrected: b1, h1, h6.The adverse event/product problem was initially reported as an adverse event only, but is now corrected to both to include product problem.The type of reportable event was initially reported as product problem.The correct type of reportable event is serious injury.The health impact grid was initially coded for c50675 (no health consequences or impact).The correct code is c172031 (serious injury/illness/impairment).
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Search Alerts/Recalls
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