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Model Number 2110 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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One device was returned for evaluation.Visual inspection revealed a damaged downstream occlusion (dso) seal.The event history log was not downloaded.Functional testing could not replicate the reported issue.The root cause was unknown.The dso seal was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
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Event Description
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It was reported that during use, the device exhibited an occlusion alarm without the presence of an occlusion.Per the reporter, there were no adverse patient effects.
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Search Alerts/Recalls
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