DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
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 cs300 intra-aortic balloon pump (iabp) screen has no image.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the reported issue.The fse replaced the coiled cable in order to fix the issue.The fse then performed a full calibration and tested the unit.The equipment worked to manufacturer's specifications.The unit passed all functional and safety tests.The unit was returned to the customer.
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Event Description
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It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) screen has no image.There was no patient involvement.
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Manufacturer Narrative
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Corrected data: b5, e3.Updated data: b4, g3, g6, h2, h10, h11.
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Search Alerts/Recalls
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