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
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit and was not able to reproduce the reported issue.The fse replaced the tank seal for precautionary purposes.The unit passed all functional and safety tests per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.(b)(6).
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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) had a helium leak.It is unknown if there was a patient involvement.However, there was no adverse event reported.
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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), h6(component codes).
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Event Description
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N/a.
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Search Alerts/Recalls
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