Catalog Number 0998-00-0800-53 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested.A supplemental report will be sent upon receiving this information.
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Event Description
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The customer reported that the cardiosave intra-aortic balloon pump (iabp) had a helium leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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A getinge service territory (stm) evaluated the iabp and tightened the internal helium tank helium line.The iabp then passed all calibration, functional and safety tests that were performed.The iabp was returned to the customer and 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) had a helium leak.It is unknown the circumstances under which the event occurred.However, no patient involvement or adverse event was reported.
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Search Alerts/Recalls
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