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Model Number N/A |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A third party distributor performed service repairs in relation to this reported event.Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).
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Event Description
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It was reported by the distributor that prior to use, the cs100 intra-aortic balloon pump (iabp) unexpectedly shutdown after the unit was turned on for less than one minute.It was also reported that the customer checked to ensure that the power supply was connected and attempted to restart the unit.However, the reported issue persisted and the customer switched to another iabp unit.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported by the distributor that prior to use, the cs100 intra-aortic balloon pump (iabp) unexpectedly shutdown after the unit was turned on for less than one minute.It was also reported that the customer checked to ensure that the power supply was connected and attempted to restart the unit.However, the reported issue persisted and the customer switched to another iabp unit.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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