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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Respiratory Tract Infection (2420); Unspecified Ear or Labyrinth Problem (4474); Salivary Gland Problem (4484); Swelling/ Edema (4577)
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Event Date 07/27/2021 |
Event Type
Injury
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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 alleged dry saliva glands, swelling in face, sinus dryness, fluid behind ears, headaches.The patient was prescribed antibiotics (z-pack) and mucinex for at least 3 months.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 received information alleging a cpap device's sound abatement foam became degraded and caused dry saliva glands, swelling in face, sinus dryness, fluid behind ears, headaches.The patient was prescribed antibiotics (z-pack) and mucinex for at least 3 months.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.In the initial report, section d4 was wrongly captured, corrected in this report.
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Search Alerts/Recalls
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