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Model Number DSX700T11C |
Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Cardiac Arrest (1762); Dyspnea (1816); Hypoxia (1918)
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Event Date 07/22/2021 |
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 bipap, and mechanical ventilator devices.The manufacturer received information alleging difficulty breathing/short of breath, asthma, cardiac arrest, oxygen levels drop to 70.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 difficulty breathing/short of breath, asthma, cardiac arrest, oxygen levels drop to 70 related to a bipap device's sound abatement foam.The medical intervention that the patient received in response to the event is currently unknown.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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