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Model Number DSX700T11C |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Pulmonary Edema (2020); Skin Discoloration (2074); Vomiting (2144); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Wheezing (4463); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
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Event Date 07/06/2021 |
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 information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged cough, wheezing, asthma, fluid in lungs, mucus, congestion, irritation of skin, eye irritation, upper airway tract irritation, chest pressure, sinus problem, vomiting, discoloration of face, shortness of breath, nasal/throat irritation or soreness, fatigue, drowsiness.There was no report of serious or permanent patient harm or injury.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 alleging cough, wheezing, asthma, fluid in lungs, mucus, congestion, irritation of skin, eye irritation, upper airway tract irritation, chest pressure, sinus problem, vomiting, discoloration of face, shortness of breath, nasal/throat irritation or soreness, fatigue, drowsiness related to a bipap device's sound abatement foam.There was no report of serious or permanent 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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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Search Alerts/Recalls
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