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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Apnea (1720); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2023 |
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 an issue related to a cpap device's sound abatement foam.The patient has alleged visualization of particles.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 received additional information on (b)(6) 2023 that the patient having sleep apnea and sleep dysfunction.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed. section g3, h1 and h6 updated/ corrected.In addition, appropriate codes has been added.
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Search Alerts/Recalls
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