Model Number 0998-00-0800-53 |
Device Problem
Failure to Sense (1559)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse spoke with the customer via telephone and resolved the issue.The fse instructed the customer to take the iabp out of the cart and push it back in, making sure it was plugged into the cart correctly.The iabp was detecting helium correctly after that.The iabp unit was cleared for clinical use and released to the customer.
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Event Description
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It was reported that prior to use the cardiosave intra-aortic balloon pump (iabp) was not detecting helium.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that prior to use the cardiosave intra-aortic balloon pump (iabp) was not detecting helium.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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