DATASCOPE CORP. - MAHWAH CS100 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 Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
Event Type
malfunction
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Event Description
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It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) printer was not working, it would not print.There was no patient involvement.
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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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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the unit and was able to reproduce the reported failure.To fix the issue the fse replaced the printer (0161-00-0022).The fse then performed a full calibration and tested the unit to factory specifications.The unit passed all tests performed and was returned to the customer and cleared for clinical use.
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Event Description
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It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) printer was not working, it would not print.There was no patient involvement.
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Search Alerts/Recalls
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