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Model Number 9004051 |
Device Problems
Device Alarm System (1012); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a damaged sample line.Functional testing found reported problem was verified.Occlusion was present on power up, inspected the rear sample line and it was damaged, sample line was replaced and the occlusion error was no longer present.The battery did not pass the battery life test so it was replaced and now passes the battery life test.The root cause of the reported alarm issue was found to be the rear sample line was kinked from use and handling damage that blocked airflow inside the pneumatics.Kinked and damaged rear tubing is known for resulting from improper handling and twisting of the tubing when removing and connecting the disk filter or from pushing the tubing against other devices during storage or moving.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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Event Description
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It was reported that the device was showing constant occlusion error and battery dies fast.No patient injury was reported.
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Search Alerts/Recalls
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