DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported "unit does not zero and no pressure" issue, the fse checked the keyboard function, and function checked the iabp with a test balloon and trainer and could not duplicate the issue.He then 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 cs300 intra-aortic balloon pump (iabp) was unable to zero pressure.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, e2, e3, g2, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d1, d5.
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Event Description
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N/a.
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Search Alerts/Recalls
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