Model Number N/A |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A supplemental report will be submitted when additional information is provided.Full event site name: (b)(6).
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Event Description
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It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) the counter-pulse pressure adjustment indicator in the control panel of the iabp device did not light.There is a problem with the keyboard control board.The iabp was newly installed on (b)(6) 2020, and was used for the first time on (b)(6) 2020.There was no harm or injury to patient and no adverse event was reported.
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Event Description
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It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) the counter-pulse pressure adjustment indicator in the control panel of the iabp device did not light.There is a problem with the keyboard control board.The iabp was newly installed on may 19, 2020, and was used for the first time on june 9, 2020.There was no harm or injury to patient and no adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) reported that the distributor engineer replaced the keypad control board.The iabp was cleared for clinical use.
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Search Alerts/Recalls
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