Model Number 0998-00-3023-53 |
Device Problems
Failure to Sense (1559); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit but was unable to reproduce the reported issue.He then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) failed to sense when using the fiber optic feature.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that during use the cs300 intra-aortic balloon pump (iabp) failed to sense when using the fiber optic feature.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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An additional customer contact was provided and is as follows: (b)(6), email: (b)(6) , contact department: (b)(6).
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Manufacturer Narrative
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Corrected fields - e1(initial reporter: (b)(6).A getinge field service engineer fse was dispatched to the site to evaluate the unit.He tested the system to factory specs no problem found.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.
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Event Description
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N/a.
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Search Alerts/Recalls
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