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Model Number DSX500T11 |
Device Problem
Degraded (1153)
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Patient Problems
Pneumonia (2011); Ulcer (2274); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)
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Event Date 09/16/2021 |
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 manufacturer received information alleging nasal and throat issues, nasal/throat irritation or soreness, pneumonia, sores in nose and back of throat.There was no report of serious 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 visualization of particles; nasal and throat issues, nasal/throat irritation or soreness, pneumonia, sores in nose and back of throat 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 an follow up report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow-up report will be filed.Section h6 updated in this report.
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Search Alerts/Recalls
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