Model Number N/A |
Device Problems
Battery Problem (2885); Charging Problem (2892)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to evaluate the iabp but the customer contacted the stm by phone to fix the issue.Customer reported that the unit was in rescue mode and not completely seated.Customer reseated unit and batteries started to charge.The iabp unit was back in use.
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Event Description
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It was reported that during a routine check, the battery of the cardiosave intra-aortic balloon pump (iabp) would not charge.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The date entered in the g4 field of the initial emdr was the incorrect date.The correct date is 10-dec-2020.A getinge service territory manager (stm) was not dispatched to the customer's site.The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported issue were noted.H3 other text : no evaluation necessary.
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Event Description
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It was reported that during a routine check, the battery of the cardiosave intra-aortic balloon pump (iabp) would not charge.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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