Catalog Number 0998-00-3023-53 |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/11/2021 |
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 installed a new power supply and power supply charging connector.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 during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) had a power supply related issue.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) had a power supply related issue.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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