Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Abdominal Pain (1685); Dry Eye(s) (1814); Sore Throat (2396); Respiratory Tract Infection (2420); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.There was no report of serious or permanent 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 previously receiving information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.The manufacturer received additional information that the patient also alleged nasal area stining, runny nose, skin irritation on his back and stomach area, nasal/throat irritation or soreness.The medical intervention was not specified.Sectionh2 and h6 are updated in this report.
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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.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 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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