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
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse ran device on battery power during checks, looked for any physical damage to wires and cables, but could not find any damage on internal components.Unit ran all weekend without any issues.The fse completed a pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) shut down.No patient harm, serious injury or adverse event was reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h4, h6 (investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1 (contact person).
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