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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Dehydration (1807); Headache (1880); Taste Disorder (4422); Unspecified Respiratory Problem (4464)
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Event Date 11/10/2021 |
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 an issue related to a cpap device's sound abatement foam.The patient has alleged dehydration, metallic taste, congestion, headache there was no report of patient harm or injury. there was no medical intervention required by the patient. 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 visualization of particles related to a cpap device's sound abatement foam.The patient has alleged dehydration, metallic taste, congestion, headache.There was no report of patient harm or injury.After the second attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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 updated in this report.
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Search Alerts/Recalls
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