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Model Number N/A |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and found problem with the 5000 hours preventive maintenance kit.The fse replaced the kit and the problem was solved.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
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Event Description
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It was reported that during a check, the cs300 intra-aortic balloon pump (iabp) had a problem with the 5000 hours preventive maintenance kit and it needs to be replaced.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a check, the cs300 intra-aortic balloon pump (iabp) had a problem with the 5000 hours preventive maintenance kit and it needs to be replaced.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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After further review, an initial emdr for this complaint was incorrectly submitted.This is a non-reportable complaint with a classification of "other", making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel in your database.
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Search Alerts/Recalls
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