The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused worsening neurological symptoms such as dizziness, vertigo, headaches, tinnitus and visual disturbances.The patient did receive medical intervention and reported to have seen a physician and has been placed on permanent disability.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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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 previously received information alleging visualization of particles related to a cpap device's sound abatement foam and caused worsening neurological symptoms such as dizziness, vertigo, headaches, tinnitus and visual disturbances.The patient did receive medical intervention and reported to have seen a physician and has been placed on permanent disability.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 has been updated in this report.
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