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Model Number DSX400S11 |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Weight Changes (2607); Cough (4457); Unspecified Respiratory Problem (4464); Decreased Appetite (4569)
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Event Date 07/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device not returned to the manufacturer.
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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 coughing, soreness of the back, no appetite, weight loss and soreness of the nose while using the device.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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The manufacturer was previously 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 coughing, soreness of the back, no appetite, weight loss and soreness of the nose while using the device.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Search Alerts/Recalls
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