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Model Number DSX500S11 |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Respiratory Tract Infection (2420); Speech Disorder (4415)
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Event Date 11/10/2021 |
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, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged nasal irritation, sore throat, loosing voice.There was no report of serious or permanent patient harm or injury.The device was returned and could not confirmed the customer allegation.
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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 a cpap device's sound abatement foam.The manufacturer received information alleged nasal/throat irritation, soreness, loosing voice.There was no report of serious or permanent harm or injury.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 one errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section h6 were updated in this report.
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Search Alerts/Recalls
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