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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Abdominal Pain (1685); Flatus (1865); Nausea (1970); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2021 |
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 and mechanical ventilator devices.The manufacturer received information alleging coughing, feeling sick, nausea, abdominal pain, bloating.There was no report of permanent or serious patient harm or injury.
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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 received information alleging coughing, feeling sick, nausea, abdominal pain, bloating related to a cpap device's sound abatement foam.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 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.Section h6 updated in this report.
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Search Alerts/Recalls
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