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Model Number DSX500T11 |
Device Problem
Degraded (1153)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Pain (1994); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Wheezing (4463); Eye Infections (4466); Dry Mouth (4485)
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Event Date 03/03/2022 |
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 having runny eyes, sore throat, dry mouth, wheezing, coughing,difficulty in breathing, skin irritation around eye areas, lungh infection, chest tight, back pain while coughing, nasal/throught irritation or soreness.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 runny eyes, sore throat, dry mouth, wheezing, coughing,difficulty in breathing, skin irritation around eye areas, lungh infection, chest tight, back pain while coughing, nasal/throught irritation or soreness.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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