Model Number DSX400H11C |
Device Problem
Degraded (1153)
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Patient Problem
Hypoxia (1918)
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Event Date 09/13/2021 |
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 low oxygen.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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged low oxygen.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 no errors found. the manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit scrapped due to age.
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Manufacturer Narrative
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Section h10 had incorrect information about device evaluation which should be as below.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual finding 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 2 errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Unit scrapped.Section h10 is corrected.
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Search Alerts/Recalls
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