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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Red Eye(s) (2038); Sore Throat (2396); Respiratory Tract Infection (2420); Sleep Dysfunction (2517); Unspecified Respiratory Problem (4464)
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Event Date 09/30/2021 |
Event Type
malfunction
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Event Description
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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, and mechanical ventilator devices.The manufacturer received information alleging nasal/throat irritation or soreness, irritated red eye, irritation in respiratory tract irritation, headache, sleepy all the time.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 nasal/throat irritation or soreness, irritated red eye, irritation in respiratory tract, headache and sleepy all the time related to a cpap device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's service centre for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of device was inspected.The device powered on, and airflow was confirmed.The device's downloaded logs were reviewed by manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer allegation.Section d5 was not reported in the previous report, which correctly updated to patient/ consumer in this follow up report.
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Search Alerts/Recalls
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