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Model Number DS960HS |
Device Problem
Degraded (1153)
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Patient Problems
Chest Pain (1776); Headache (1880); Sore Throat (2396); Cough (4457); Unspecified Ear or Labyrinth Problem (4474); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/15/2021 |
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 patient states having migraines,problem with ears,chest pressure,nasty cough,sore throat and nasal or throat irritation.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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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 migraines,problem with ears,chest pressure,nasty cough,sore throat and nasal or throat irritation related to a bipap device's sound abatement foam.There was no report of patient harm or injury.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.Section h6 was corrected updated in this report.
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Search Alerts/Recalls
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