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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 03/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that the device had a distal occlusion, and the dso sensor is bubbled.There was no patient involvement and no patient or clinical injury reported.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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One device was returned for evaluation.Visual inspection revealed a worn upstream occlusion (uso) seal.Event history log review was not applicable.Functional testing was unable to replicate the reported issue; no issue was found.The root cause was undetermined.No repair was needed.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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Search Alerts/Recalls
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