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
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse observed that the safety disk not fully inserted to console inlet.The fse observed that the locking tabs needed adjustment.The fse adjusted tension on tabs to secure safety disk in locking position.The safety disk tab adjustment corrected locking issue.The unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) displayed low vacuum readings.This event was noted by the end user.It is unknown the circumstances under which the event occurred.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, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d1, d10.
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