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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Abdominal Pain (1685); Asthma (1726); Headache (1880); Anxiety (2328); Sore Throat (2396); Speech Disorder (4415); Cough (4457); Unspecified Respiratory Problem (4464)
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Event Date 09/18/2021 |
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, and mechanical ventilator devices.The manufacturer received information alleging throat issues, voice feels gravity, cough, asthma attacks, headaches, restlessness, very upset stomach, dry sore throat.There was no report of serious or permanent 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 related to a cpap device's sound abatement foam.The manufacturer received information alleging throat issues, voice feels gravily, cough, asthma attacks, headaches, restlessness, very upset stomach, dry sore throat.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 updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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Search Alerts/Recalls
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