Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and reported that the device displayed an autofill failure error when the device was first turned on.It was seen that it gave an error when tried with catheter.After all the tests were done, it was operated again with the trainer simulator at different ecg values.The device was tested in semi-auto and internally several times.Subsequently, the unit was turned off and on again and re-run at the same ecg values.The device did not fail again.The iabp was delivered to the customer in working condition.(b)(6).
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) displayed an auto failure error when first turned on.It is unknown under which circumstances this 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 cs100 intra-aortic balloon pump (iabp) displayed an auto failure error when first turned on.It is unknown under which circumstances this 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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