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Device Problem
Degraded (1153)
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Patient Problems
Nausea (1970); Ulcer (2274); Sleep Dysfunction (2517); Unspecified Heart Problem (4454); Cough (4457)
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Event Date 07/29/2022 |
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 voluntary medwatch (mw5110963).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to nausea,sores in nose,coughing,several heart issue,sleep dysfunction.There was no report of serious 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 previously received information alleged nausea, sores in nose, coughing, several heart issue, sleep dysfunction related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There is no customer information hence we cannot reach out to the customer 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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