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Model Number DSX400T11C |
Device Problem
Degraded (1153)
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Patient Problems
Unspecified Kidney or Urinary Problem (4503); Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging visualization of particles related to a cpap device's sound abatement foam.There was no report of 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 previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Additional information was received that the patient is also alleging a brain tumor and kidney disease while using the device.This is now being reported as an adverse event.
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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 an issue related to a cpap device's sound abatement foam and patient alleged visualization of particles, brain tumor and kidney disease.The patient did not report to receive medical intervention.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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