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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Cataract (1766); Dry Eye(s) (1814); Dyspnea (1816); Headache (1880); Nausea (1970); Neuropathy (1983); Vertigo (2134); Blurred Vision (2137); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/14/2021 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged seeing particles in the device.The patient alleged breathing issue, leg shake, copd, nausea, dizziness, blurry eyes, headache, heart surgery, severe panic attacks,oxygen use in 24/7, eye irritation.Patient also alleged having heart surgery, vertigo, neuropathy, cataract, spots on brain.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 previously reported an allegation of an issue related to sound abatement foam. additional information was received and section b5 should be reported as: 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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged breathing issue, leg shake, copd, nausea, dizziness, blurry eyes, headache, heart surgery, severe panic attacks,oxygen use in 24/7, eye irritation.Patient also alleged having heart surgery, vertigo, neuropathy, cataract, spots on brain.The reported event of heart surgery and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient. the device has not yet returned to the manufacturer for evaluation.The patient has swapped out the deice at the distributor and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed. section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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Search Alerts/Recalls
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