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Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Cancer (3262)
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Event Date 03/28/2024 |
Event Type
Death
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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.
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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 lung cancer, and back pain.The patient passed away.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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