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
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2020 |
Event Type
malfunction
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) units touchscreen was not working, ecg cables were not present and replaced.There was no patient involvement.
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Manufacturer Narrative
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The getinge service technician that encountered the issue reported that no ecg cables were present during testing.The technician provided / replaced ecg cables (0012-00-1812-01 & 0012-00-1813-01) this call.Device passed all functional and safety tests according to factory specifications.The iabp was returned to customer and cleared for clinical use.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
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Search Alerts/Recalls
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