Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/24/2018 |
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge was not requested to service the iabp.However, a new removable power supply was shipped to the customer as goodwill.The full name of the event site noted is (b)(6) medical center (tp).
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Event Description
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The customer reported that the cardiosave intra-aortic balloon pump (iabp) rescue power supply was not functional, and that the power supply cord was replaced last year, but was barely used and was sitting on a shelf.The circumstance under which the event occurred is unknown; however, there was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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The transport power supply was replaced by biomed and the iabp was cleared for clinical use.
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Event Description
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The customer reported that the cardiosave intra-aortic balloon pump (iabp) rescue power supply was not functional, and that the power supply cord was replaced last year, but was barely used and was sitting on a shelf.The circumstance under which the event occurred is unknown; however, there was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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