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Model Number DS560HS |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pulmonary Edema (2020); Dizziness (2194); Pharyngitis (2367); Sore Throat (2396); Respiratory Tract Infection (2420); Cancer (3262)
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Event Date 08/25/2023 |
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, respiratory tract irritation, dizziness and/or headache, hypersensitivity, asthma (new or worsening), inflammatory response, lung disease, reduced cardiopulmonary reserve, cancer, basal cell carcinoma; renal cell carcinoma.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.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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H3 other text : device not returned to manufacturer.
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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 nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, asthma (new or worsening), inflammatory response, lung disease, reduced cardiopulmonary reserve, cancer, basal cell carcinoma; renal cell carcinoma.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.On the previously submitted report, the type of reported complaint was incorrect.It is corrected on this report.
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Search Alerts/Recalls
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