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Model Number DSX700H11 |
Device Problem
Degraded (1153)
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Patient Problem
Respiratory Failure (2484)
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Event Date 02/19/2024 |
Event Type
Injury
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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 respiratory failure.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.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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H3 other text : device not returned to manufacturer.
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Manufacturer Narrative
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The manufacturer previously reported information 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 respiratory failure.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The device was returned to a third-party service center.During the evaluation of the device at the third-party service center the complaint was not confirmed and there were no visible foam particles found.The device was scrapped.
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Search Alerts/Recalls
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