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Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Chronic Obstructive Pulmonary Disease (COPD) (2237)
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Event Date 09/25/2023 |
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 an issue related to a cpap device's sound abatement foam.The patient has alleged asthma (new or worsening) and copd has worsened.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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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device has not been returned to manufacturer.
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Search Alerts/Recalls
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