DATASCOPE CORP. 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
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Event Description
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It was reported that every time the patient coughed, the cs300 intra-aortic balloon pump (iabp) unit had leak in circuit alarm.There was no patient harm.
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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 during use, the cs300 intra-aortic balloon pump (iabp) had a check iab catheter¿and a leak in iab circuit alarm every time the patient coughed.There was no patient harm reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit and could not duplicate any failure when tested with test balloon and patient simulator.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.
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Event Description
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N/a.
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Manufacturer Narrative
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Udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
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Search Alerts/Recalls
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