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Model Number N/A |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The display was distorted and flipping.To fix the issue, the fse replaced the display, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that the display of the cs300 intra-aortic balloon pump (aibp) flickered when touched.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
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Search Alerts/Recalls
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