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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Pain (1994); Red Eye(s) (2038); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/09/2020 |
Event Type
malfunction
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Event Description
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The manufacturer received a voluntary medwatch (mw5105722) in which it was alleged by eye, sinus problems, gum bleeding, pain, red and painful eyes, congestion sinus, phlegm, headache.There was no report of serious or permanent 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 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 by eye, sinus problems, gum bleeding,pain, red and painful eyes, congestion sinus, severe phlegm, headache related to a cpap 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.
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Search Alerts/Recalls
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