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Device Problem
Degraded (1153)
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Patient Problem
Fatigue (1849)
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Event Date 01/11/2011 |
Event Type
Injury
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Manufacturer Narrative
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No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973 and z-1974.H3 other text : device not returned.
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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 voluntary medwatch (mw5148187).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged pulmonary damage/inflammatory response.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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