DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-64 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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) had no tightening system.The ready console arrived at the customer without clamping system or helium bottle.There was no patient involved.
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Manufacturer Narrative
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Updated data: b4, e1(initial reporter), e2, e3, g2, g3, g6, h2, h10.
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Event Description
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N/a.
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Manufacturer Narrative
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The field service engineer evaluated the unit and replaced the clamping system knob and tank valve.All functional and safety checks have been performed to meet factory specifications.
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Event Description
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N/a.
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Search Alerts/Recalls
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