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Model Number DSX500S11 |
Device Problem
Degraded (1153)
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Patient Problems
Hemoptysis (1887); Pneumonia (2011); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/07/2021 |
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/bipap) device's sound abatement foam.The patient has alleged nasal issue, coughing up blood, nasal irritation, sore throat, coughing, congestion, pneumonia.There was no report of serious or permanent 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 previously reported a cpap device's sound abatement foam alleging nasal issue, coughing up blood, nasal irritation, sore throat, coughing, congestion, pneumonia.The manufacturer has received the additional information alleging disabled.There was no report of serious or permanent patient harm or injury.
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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 nasal issue, coughing up blood, nasal irritation, sore throat, coughing, congestion, pneumonia, diabled 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 a updated 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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