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Model Number DS560HS |
Device Problem
Degraded (1153)
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Patient Problems
Cyst(s) (1800); Headache (1880); Burning Sensation (2146); Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2023 |
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 has alleged to 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 previously reported 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 to 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.In previous report section h "type of reported complaint" was incomplete.In this report section h has been updated/corrected.
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Manufacturer Narrative
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The manufacturer previously reported 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 to 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.New information has been added that the patient alleged burning in nasal passages and a very bad headache, cysts in my nasal passages, brain tumor, underwent brain surgery, had to have chemotherapy and radiation to treat the tumor.Section-b "adverse event/product problem" and "outcomes attributed to ae", section-g "date received by mfg (rfb)" and section-h "patient outcome code grid" and "health impact grid" has been updated / corrected.
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Search Alerts/Recalls
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