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Model Number DS450S |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Lymphoma (3263); Respiratory Insufficiency (4462)
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Event Date 04/25/2022 |
Event Type
Injury
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Event Description
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The manufacturer received a voluntary medwatch (mw5115836) regarding field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that they have experienced episodes of decreased lung function, persistent upper respiratory symptoms, and shortness of breath.The patient was hospitalized with left lung pleurisy and 3 liters of fluid was drained from that lung.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 received a voluntary medwatch (mw5115836) regarding field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that they have experienced episodes of decreased lung function, persistent upper respiratory symptoms, and shortness of breath.The patient was hospitalized with left lung pleurisy and 3 liters of fluid was drained from that lung.On the previously submitted report, section h was listed as product problem and was inadvertently wrong. it is corrected on this report as a serious injury.
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Search Alerts/Recalls
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