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
Appropriate Term/Code Not Available (3191)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
Event Type
malfunction
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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, the cardiosave intra-aortic balloon pump (iabp) units housing is missing.
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Event Description
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It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) units housing is missing.There was no patient involved.
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Manufacturer Narrative
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Updated sections: b4, e2, e3, g2, g3, g6, h2, h10, h11.Corrected sections: b5, b6, b7, d10, h6(health clinical & impact codes).
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse that evaluated the unit observed that the doppler door and hinges were broken off of the cart.In order to fix the issue, the fse replaced the storage bin and chassis.The unit then passed all functional and safety checks to factory specifications.The unit was then returned to the customer and cleared for clinical use.
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Event Description
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N/a.
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Search Alerts/Recalls
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