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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Sneezing (2251); Sore Throat (2396); Respiratory Tract Infection (2420); Embolism/Embolus (4438); Cough (4457); Epistaxis (4458)
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Event Date 10/28/2021 |
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 difficulty in breathing, nasal irritation, throat soreness, runny nose, nose bleed, sneezing, cough, blood clots in lungs, there was no report serious or permanent of 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 difficulty in breathing, nasal irritation, throat soreness, runny nose, nose bleed, sneezing, cough and blood clots in lungs 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.
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Search Alerts/Recalls
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