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Model Number DS960TS |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Headache (1880); Nausea (1970); Dizziness (2194); Balance Problems (4401)
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Event Date 12/21/2021 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging an issue related to bipap device's sound abatement foam.The patient alleges to have asthma, headaches, dizziness, nausea, and unsteadiness.There is no report of medical intervention being required.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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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 to have asthma, headaches, dizziness, nausea, and unsteadiness related to a bipap device's sound abatement foam.There is no report of medical invervention being required.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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