Model Number N/A |
Device Problem
Inaccurate Synchronization (1609)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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) was not required to be reviewed as 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) was dispatched to evaluate this unit and was unable to duplicate the reported issue.While running test, the fse was able to have his pressures verified with the mini sim and reported that the units external option was not for pressure.The unit passed all functional and safety tests per factory specifications.The unit was returned to customer and cleared for clinical use.(b)(6).
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Event Description
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It was reported that the cs300 intra-aortic pump (iabp) will not show the pressure when slaved to monitor.There was no patient harm or injury and no adverse event reported.
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Event Description
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It was reported that the cs300 intra-aortic pump (iabp) will not show the pressure when slaved to monitor.There was no patient harm or injury and no adverse event reported.
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Search Alerts/Recalls
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