DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit, but was unable to reproduce the reported issue.The fse noted the power activity logs did not show any activity of powering on and registering a power off.The fse 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.
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Event Description
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It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) was shutting off randomly and without warning or alarming.It was also reported that another iabp unit was used to continue patient therapy.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, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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