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Model Number UDSX500S11F |
Device Problems
Degraded (1153); Nonstandard Device (1420); Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to manufacturer.
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Event Description
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The manufacturer received a voluntary medwatch (mw5147824-1) in reference to the field safety notice related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging black particles on mask contamination and defective device.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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