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
Inability to Auto-Fill (1044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit for the reported issue fill fail and was able to reproduce the reported issue.To fix the issue, the fse removed and replaced the pim module and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had an autofill error.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).
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