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Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging filters are turning black.The end user alleges machine is not working properly and he was scared using the device because the filter turns into black.Patient would like to request a replacement 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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Manufacturer Narrative
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Since 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 to manufacturer.
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Search Alerts/Recalls
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