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Device Problem
Degraded (1153)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Respiratory Tract Infection (2420); Unspecified Heart Problem (4454); Cough (4457); Wheezing (4463)
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Event Date 12/09/2021 |
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.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to high pressure severe,heart racing,wheezing,coughing,throat irritation.There was no report of patient harm or injury.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 previuosly received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to high pressure severe,heart racing,wheezing,coughing,throat irritation.There was no report of serious or permanent patient harm or injury.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 updated in this report.
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Search Alerts/Recalls
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