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Device Problem
Degraded (1153)
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Patient Problem
Breast Cancer (1759)
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Event Date 10/02/2023 |
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 philips cpap device's sound abatement foam.The patient has alleged visualization of particles.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Patient's attorney reporting allegations of brest cancer.No other clinical information or medical interventions were reported.
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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 : the device has not yet been returned to the manufacturer.
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Search Alerts/Recalls
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