Model Number 0998-00-0800-53 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device ((b)(4)): a getinge field service engineer (fse) was dispatched to evaluate the iabp and found a metal burr at the end of threading of helium tank knob.It was not allowing knob to be fastened to high pressure regulator.To fix the issue, the fse cleared metal burr from threading and was able fasten the helium tank down without any further problems.All functional and safety checks were performed 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.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a loose screw on the helium tank.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Search Alerts/Recalls
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