Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2018 |
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) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.
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Event Description
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It was reported that, during patient use, the cardiosave intra-aortic balloon pump (iabp) had intermittent startup issues; circle just spins.There was no injury or adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) could not duplicate the reported malfunction.However, the fse replaced the video generator board and installed software as a precautionary measure.The iabp passed all functional and safety tests per factory specifications, and was returned to the customer and cleared for clinical use.
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Event Description
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It was reported that, during patient use, the cardiosave intra-aortic balloon pump (iabp) had intermittent startup issues; circle just spins.There was no injury or adverse event reported.
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Search Alerts/Recalls
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