DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-53 |
Device Problem
No Display/Image (1183)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2023 |
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) units display screen is black.
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Manufacturer Narrative
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Updated data: b4,g3,g6,h2,h10,h11.Corrected data: b5,b6,b7,d10,h6(clinical & impact).
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Event Description
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It was reported that before use, the cs300 intra-aortic balloon pump (iabp) units display screen is black.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10, h11 corrected fields: d1, d3.A getinge field service engineer (fse) checked the unit and to fix the issue he replaced the video receiver pcb.The fse then completed pm with full calibration, functional testing and safety check to factory specifications.The unit was then returned to the customer and cleared for customer use.
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Search Alerts/Recalls
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