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 Problems
Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
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) failed pneumatic test.
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Manufacturer Narrative
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Corrected data: b5, e3, h6 (clinical , problem and impact code).Updated data: b4, g3, g6, h2, h10, h11.
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Event Description
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It was reported by the biomed that during use, the cs300 intra-aortic balloon pump (iabp) failed pneumatic test and there was a leak in iab.There was no patient harm reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse found that the biomed failed to zero the pressure before starting the test.The fse was unable to duplicate the issue.The fse performed functional and safety tests successfully.
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Search Alerts/Recalls
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