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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Hemoptysis (1887); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
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 coughing up blood.There was no report of 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 previously 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 coughing of blood.There was no report of patient harm or injury.Manufacturer received corrected information alleging the patient coughing of blood.The medical intervention was not specified.
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Search Alerts/Recalls
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