Model Number N/A |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp and was unable to reproduce the reported issue.However, the fse was able to verify the "leak iab circuit" in fault log, and determined the alarm triggered to specifications.The unit passed all leak tests.The fse then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.(b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had a leak in the circuit.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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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had a leak in the circuit.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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