Catalog Number 0998-UC-3013-53 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the issue.The video receiver board from a demo iabp was removed and placed in the iabp until the customer can purchase new parts.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that prior to use the cs100 intra-aortic balloon pump (iabp) display was distorted.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that prior to use the cs100 intra-aortic balloon pump (iabp) display was distorted.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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