Model Number 0998-00-0800-53 |
Device Problems
Charging Problem (2892); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported by the clinical engineer that the cardiosave intra-aortic balloon pump (iabp) wouldn¿t charge.Customer was advise to check to see if it was a rescue or hybrid configuration but she wasn¿t sure.Advised to pull the latch and then slide the pump out 4-6 inches and firmly slide back onto the cart.Customer powered unit up and it said ¿hybrid¿ and both batteries were completely depleted but it appeared to be charging.Customer was advised to leave it plugged in for several hours and check back.Customer mentioned that when they were looking at the batteries, there appeared to be some ¿clear fluid¿ and "white crust" near the batteries, they were advised to get more information from the person who gave them this pump.There was no patient involvement.
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Event Description
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It was reported by the clinical engineer that prior to use on patient, the cardiosave intra-aortic balloon pump (iabp) wouldn¿t charge.Customer was advise to check to see if it was a rescue or hybrid configuration but she wasn¿t sure.Advised to pull the latch and then slide the pump out 4-6 inches and firmly slide back onto the cart.Customer powered unit up and it said ¿hybrid¿ and both batteries were completely depleted but it appeared to be charging.Customer was advised to leave it plugged in for several hours and check back.Customer mentioned that when they were looking at the batteries, there appeared to be some ¿clear fluid¿ and "white crust" near the batteries, they were advised to get more information from the person who gave them this pump.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.
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Search Alerts/Recalls
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