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 of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: the getinge field service engineer (fse) resolved the issue by replacing the assembly dss datasette cs300, and then performed functional and safety checks to meet 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.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).The full name of the event site was shortened due to field character limit; the full name is: (b)(6) hospital.
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Event Description
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It was reported that during preventative maintenance the cs300 intra-aortic balloon pump (iabp) unit would not navigate to the diagnostic menu and displayed electrical test failure code #30.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, h10.
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Event Description
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N/a.
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Search Alerts/Recalls
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