DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/18/2020 |
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.The getinge service territory manager (stm) that encountered the issue during pm reported that the manifold test was failing.To verify, the stm ran a few test but obtained the same results.Further more, the stm inspected for signs of fluid infiltration inside device but no fluids were found.The stm replaced drive manifold assembly and completed functional tests without any further issue.The cardiosave iabp services were completed.The stm then completed the preventive maintenance (pm); safety, calibration, and functionality checks to factory specifications.The iabp was released to customer and cleared for clinical use.(b)(6).
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Event Description
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It was reported by a getinge service territory manager (stm) during preventive maintenance (pm).The cardiosave intra-aortic balloon pump was failing drive manifold leak test.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.
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Event Description
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It was reported by a getinge service territory manager (stm) during preventive maintenance (pm).The cardiosave intra-aortic balloon pump was failing drive manifold leak test.There was no patient involvement, and no adverse event reported.
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