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Device Problem
Degraded (1153)
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Patient Problems
Pulmonary Embolism (1498); Adult Respiratory Distress Syndrome (1696)
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Event Date 10/12/2023 |
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 respiratory distress and blood clot in lung.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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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 not returned to manufacturer.
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Search Alerts/Recalls
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