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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2022 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.There is no allegation of serious or permanent 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 previously receiving information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.The manufacturer received additional information alleging the patient also having seizures.The medical intervention was not specified.Section b1, b2, h1, h6 are updated in this report.
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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 visualization of particles and seizures related to a cpap device's sound abatement foam.The reported event of seizures believed to be caused by visualized particles in the device and its reported severity was reviewed by the pms clinical expert.This event is assessed as not related to the device in this case.The medical intervention was not specified.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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