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Model Number N/A |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/05/2018 |
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) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service representative also reported that the mainboard was broken, and that the customer does not want to repair the iabp, and that they will be replacing the iabp device next year with the successor model cardiosave.Additional information has been requested, and we will report accordingly if it becomes available.The full initial reporter name is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) could not boot properly.The start up aborted after one second.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) could not boot properly.The start up aborted after one second.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and there was no adverse event reported.
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Manufacturer Narrative
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The getinge field service engineer (fse) later reported that the customer changed their decision and wanted the iabp repaired.The fse reported that the issue was not the main board but the power supply being defective, and due to that, the batteries could not be charged and did not supply power to the iabp unit.The iabp unit attempted to power up while in battery mode, but shut off immediately after one second because of a short circuit in the power supply.To fix this issue, the fse replaced the power supply and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Search Alerts/Recalls
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