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Model Number DSX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/08/2023 |
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/ bipap and mechanical ventilator devices.The manufacturer received information alleging ear drums opened up, sinus, lung and digestive system problems.There was no report 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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Search Alerts/Recalls
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