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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908); Chronic Obstructive Pulmonary Disease (COPD) (2237); Diabetic Ketoacidosis (2364); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/21/2022 |
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 and mechanical ventilator devices.The manufacturer received information alleging copd, 2 stints in the heart, high blood pressure, takes 10 prescription medicines, afib, types 2 diabetes.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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In previous report, mentioned incorrectly, which has been updated in this report.
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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 alleging an issue related to a cpap device's sound abatement foam became degraded and caused copd, 2 stints in the heart, high blood pressure, afib, types 2 diabetes.The patient report to receive medical intervention.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.Corrected information was provided in section a1.Section h6 was corrected and updated in this report.
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Search Alerts/Recalls
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