RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11 |
Device Problem
Degraded (1153)
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Patient Problems
Angina (1710); Dyspnea (1816); Headache (1880); Dizziness (2194)
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Event Date 01/31/2022 |
Event Type
malfunction
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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 alleged that the filters are dirty and that there are particles in the tubing/chamber.Patient also alleges shortness of breath, headaches, dizziness, and chest pain.The patient alleges that the device has a strange odor and is not registering the data properly.There is no allegation of serious or permanent harm or injury.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 that the filters are dirty and that there are particles in the tubing/chamber.Patient also alleges shortness of breath, headaches, dizziness, and chest pain.The patient alleges that the device has a strange odor and is not registering the data properly.There was no report of 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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