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Device Problem
Degraded (1153)
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Patient Problems
Burning Sensation (2146); Sore Throat (2396); Respiratory Tract Infection (2420); Wheezing (4463)
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Event Date 09/13/2021 |
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 cpap device's sound abatement foam.The patient has alleged burning sensation in throat, wheezing, increase use of inhaler, nasal/throat irritation or soreness.There was no medical intervention required by the patient.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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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 burning sensation in throat, wheezing, increase use of inhaler, nasal/throat irritation or soreness.There was no medical intervention required by the patient.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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.
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Search Alerts/Recalls
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