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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Abdominal Pain (1685); Chest Pain (1776); Headache (1880); Nausea (1970)
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Event Date 07/12/2021 |
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 nausea, chest pain, headache, stomach pain, chest pressure.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 reported an allegation of an issue related to cpap device's sound abatement foam and became degraded and caused the patient to have nausea, chest pain, headache, stomach pain, chest pressure.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 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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