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Model Number DSX500T11W |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); High Blood Pressure/ Hypertension (1908); Sore Throat (2396)
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Event Date 08/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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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 cpap device's sound abatement foam.The patient has alleged headache, blood pressure is running right now, eye irritation.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for evaluation.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 previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 an issue related to a cpap device's sound abatement foam.The patient has alleged dry throat, headache, eye irritation and his blood pressure is running high.The reported event of high blood pressure (hypertension), and its reported severity was reviewed by the manufacture¿s clinical expert.This event was assessed as serious injury.There was no medical intervention reported by the patient.The device has not yet returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.Section was missed to capture in the previous report, which was updated in this report.Section(s) has changed related to the complaint changing from the reported product problem to adverse event and product problem.Section has changed to reflect a serious injury.Section health effect- impact code has been updated.
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Search Alerts/Recalls
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