Catalog Number 0998-00-0800-53 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/23/2017 |
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 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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The customer reported that a loaner intra-aortic balloon pump (iabp) would not boot up.This event occurred during service/testing by the customer.No patient was involved and no adverse event has been reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched and reported that the iabp was damaged during shipping and the fse replaced the display hinge cover and labels.The fse also replaced the monitor board and pinched wires to resolve the reported failure.The iabp was then cleared for clinical use.
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Event Description
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The customer reported that a loaner intra-aortic balloon pump (iabp) would not boot up.This event occurred during service/testing by the customer.No patient was involved and no adverse event has been reported.
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Search Alerts/Recalls
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