Model Number N/A |
Device Problems
No Audible Alarm (1019); Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/30/2020 |
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 as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm was unable to reproduce the issue.No failures were shown in the logs.The stm replaced the power supply assembly as a precaution and possible source of the issue.All connections were checked.The stm 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 use on a patient the cs300 intra-aortic balloon pump (iabp) was intermittently shutting off.It was also later clarified that the unit shut down three times with no alarms or warning.The power was cycled and the assist therapy was able to continue.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) was intermittently shutting off.It was also later clarified that the unit shut down three times with no alarms or warning.The power was cycled and the assist therapy was able to continue.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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