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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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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.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 of asthma and worsening chronic obstructive pulmonary disease (copd).The manufacturer was made aware of this complaint through a representative of the customer.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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