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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Angina (1710); Dyspnea (1816); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457)
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Event Date 10/26/2021 |
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 cough, chest pain, nasal/throat 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 previously reported receiving information alleging an issue related to the cpap device's sound abatement foam.The patient alleged cough, chest pain, nasal/throat irritation or soreness.The patient also alleges breathing problem.In section h6, health effect - clinical code : 1816 was missing in previous report, which is now correctly updated in this follow up 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 an issue related to a cpap device's sound abatement foam.The patient alleged cough, chest pain, nasal/throat irritation or soreness.There was no report of serious or permanent 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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