DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse connected the helium tank, powered the unit on and successfully completed all power-up self-tests without any alarms or errors, and displayed 'system test ok' message.The fse connected a known system trainer, as well as a known balloon and initiated auto-fill.The unit successfully completed auto-fill and continued pumping at 80bpm for approximately 60 minutes without any alarms or abnormal function occurrences.Although the fse was not able to reproduce the reported issue, the fse observed (7) iab catheter restriction alarms on (b)(6) 2021 and (2) iab catheter restriction alarms on (b)(6) 2021.The fse then performed a full pm with calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that prior to patient transport, the cardiosave intra-aortic balloon pump (iabp) had a low flow issue.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, b6, b7, d11, g4, g7, g8, h2, h6(investigation type), h10, h11.Corrected fields: d5, g1(contact person), h4, h6(component codes).
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Event Description
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N/a.
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Search Alerts/Recalls
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