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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Cancer (3262); Renal Impairment (4499)
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Event Date 09/18/2023 |
Event Type
Death
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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 cancer, end of state renal disease, and death.Medical intervention was not specified.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 from the patient attorney alleging cancer, end of state renal disease, and death.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.On the previously submitted report, the wrong type of reported complaint was selected (serious injury).It is corrected on this report and updated to "death.".
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Search Alerts/Recalls
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