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Model Number 773662 |
Device Problem
Air/Gas in Device (4062)
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Patient Problems
Flatus (1865); Nausea (1970); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Event Description
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The customer reported that they have been dealing with excess air in the tubing on a regular basis which has exacerbated their gi issues.Additional information provided by the customer stated that the issue has been intermittent and ongoing.The customer has had symptoms of nausea, windy and bloating.The customer did not require any treatment or intervention for the reported incident and did not see a health care professional for these issues.
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Search Alerts/Recalls
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