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Model Number DSX400T11 |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); High Blood Pressure/ Hypertension (1908); Cancer (3262)
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Event Date 08/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : 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 asthma (new or worsening), lung disease, cancer (maligmalit carcinoid lung tumor) and high blood pressure.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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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 asthma (new or worsening), lung disease, cancer (maligmalit carcinoid lung tumor) and high blood pressure.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.After further review, this report is now being filed as an adverse event instead of product problem and adverse event both.Sections b1 and h6 (health effect - impact code) has been corrected/updated in this report.
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Search Alerts/Recalls
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