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Device Problem
Degraded (1153)
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Patient Problem
Pulmonary Dysfunction (2019)
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Event Date 10/09/2023 |
Event Type
malfunction
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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.Per the legal department, the patient has alleged lung disease.No other clinical information or medical intervention was specified.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 : the device has not been returned to the manufacturer for analysis.
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Search Alerts/Recalls
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