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
Circuit Failure (1089)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that while servicing a unit by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) solenoid driver board voltages were out of range for blood back detector.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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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)(64.Testing of actual/suspected device (10/3233): the getinge field service engineer (fse) that encountered the issue was unable to correct the voltages per service manual instruction.To fix the issue, the fse replaced the solenoid driver board and the blood test tubing, and performed full 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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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6, h10.
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Event Description
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N/a.
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Search Alerts/Recalls
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