Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/29/2018 |
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) 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.A supplemental report will be submitted when additional information is made available.
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Event Description
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It was reported that an unknown malfunction occurred on the cardiosave intra-aortic balloon pump (iabp).It is unknown under which circumstance this occurred; however, there was no patient involvement and 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 reported that the alleged malfunction was autofill related.The stm could not duplicate the reported issue.The iabp was returned to the customer and cleared for clinical use.
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Event Description
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It was reported that an unknown malfunction occurred on the cardiosave intra-aortic balloon pump (iabp).It is unknown under which circumstance this occurred; however, there was no patient involvement and no adverse event was reported.
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Search Alerts/Recalls
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