Model Number DSX200H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Tachycardia (2095); Respiratory Insufficiency (4462)
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Event Date 12/16/2021 |
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 breathing issues.There was no report of patient any serious 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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Section d.4 was incorrectly reported in previous report, which is now correctly updated in this follow-up report as dsx200h11c.
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Manufacturer Narrative
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The manufacturer previously reported received an issue related to a cpap device's sound abatement foam become degraded and caused the patient having breathing issues.There was no report of patient any serious harm or injury.In previous initial report, in section h6 health effect - clinical code, difficulty breathing was incorrectly coded as 4462.The manufacturer also marked h10 section incorrectly in previous initial report.The patient also alleged having fast heart rate, which was not included in the initial 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 heart beat is getting increased because she can not breath related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the first attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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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