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 Problems
Circuit Failure (1089); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device|10: during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered two "electrical test fails code 45 and 54" and shutdown.To fix the issue, the fse replaced the solenoid driver board (0670-00-0639e) and the main board (0670-00-0788), and then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), that the cs300 intra-aortic balloon pump (iabp) unit got system failure errors (codes 45 and 54) and shut down.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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