Catalog Number 0998-00-0800-53 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Patient Involvement (2645)
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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 per getinge 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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It was reported that the cardiosave intra-aortic balloon pump (iabp) cart was not charging the batteries.It is unknown under which circumstances this event occurred.However, there was no patient involvement, thus no adverse event was reported.
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Manufacturer Narrative
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A getinge service territory manager (stm) evaluated the iabp and replaced the coiled cable and wiring harness due to the screen blanking out when connected monitor cable was moved.In addition, the stm also found saline in the connection.The stm verified all functional and safety checks with full calibration, and the iabp was returned the iabp to the customer and cleared for clinical use.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) unit screen would blank out when connected monitor cable is moved.It is unknown under which circumstances this event occurred.However, there was no patient involvement, thus no adverse event was reported.
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Search Alerts/Recalls
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