DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had a problem with overheating on weekends.
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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 during use, the cardiosave intra-aortic balloon pump (iabp) unit had a problem with overheating on weekends.There was no patient harm reported.
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Manufacturer Narrative
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Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5,h6(impact, clinical).
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that he was unable to notice the error, but the adjustment screw of the vacuum regulator was broken, which could have caused the error.So, the fse replaced the regulator ((b)(4)).The unit then tested according to the manufacturer's and operational protocol.
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Event Description
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N/a.
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Search Alerts/Recalls
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