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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed the reported issue.The fse replaced the power supply then 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.
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Event Description
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It was reported that during a routine check performed by the customer, the cs100 intra-aortic balloon pump (iabp) was not working on mains power.It was noted that the power supply is suspected to be defective.There was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, d4 (unique identifier (udi) #), g4, g7, h2, h6 (evaluation method codes).
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Event Description
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It was reported that during a routine check performed by the customer, the cs100 intra-aortic balloon pump (iabp) was not working on mains power.It was noted that the power supply is suspected to be defective.There was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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