DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-52 |
Device Problems
Circuit Failure (1089); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
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 during commissioning performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) lost power whilst the new software was being installed.The pump failed to power up after this and the screen just had the 'maquet' logo and alarmed after awhile it was suspected the executive processor board was corrupt.There was no patient involvement.
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Event Description
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It was reported that during commissioning performed by a getinge service territory manager (stm), whilst installing software d00 for the fsn, the cardiosave intra-aortic balloon pump (iabp) had an issue with the video generator board.The unit lost power whilst the new software was being installed.The pump failed to power up after this and the screen just had the 'maquet' logo and alarmed after awhile it was suspected the executive processor board was corrupt.There was no patient involvement.
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Manufacturer Narrative
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Corrected data: b5.Updated data: b4, g3, g6, h2, h10, h11.
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Search Alerts/Recalls
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