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Model Number DSX700H11C |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Taste Disorder (4422); Swelling/ Edema (4577)
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Event Date 06/30/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged to experiencing a swollen/irritated/sore throat, spitting up reddish/pink fluid and the device has a strange taste.There was no report 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 reported an allegation of an issue related to sound abatement foam became degraded and caused swollen/irritated/sore throat, spitting up reddish/pink fluid and the device has a strange taste.This event is assessed as related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device was returned to the manufacturer's service center 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 the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.
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Manufacturer Narrative
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Section b5 in previous report should be reported as : 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 reported an allegation of an issue related to sound abatement foam became degraded and caused swollen/irritated/sore throat, spitting up reddish/pink fluid and the device has a strange taste.There was no report of serious patient harm or injury.After review, the following correction has been updated in this report.Section(s) b1, b2 has updated to reflect as product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code has been updated.
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Search Alerts/Recalls
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