Catalog Number 0998-00-3013-53 |
Device Problem
Charging Problem (2892)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested, and we will report accordingly if it becomes available.
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) battery would not charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.After charging the iabp for 8 hours, the iabp still displayed low battery, so it was confirmed that the battery was abnormal after the test.To fix the issue, the fse replaced the battery, and 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.
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Event Description
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It was reported that before use, the cs100 intra-aortic balloon pump (iabp) battery would not charge.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that before use, the cs100 intra-aortic balloon pump (iabp) battery would not charge.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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