Model Number 0998-00-0800-55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2022 |
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 customer that, the cardiosave intra-aortic balloon pump (iabp) balloon has broken.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the unit and was able to confirm that the unit was working normally.The unit passed all functional and safety checks to factory specifications.The unit was then returned to the customer and cleared for clinical use.
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Event Description
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It was reported by the customer that during the use of machine, the cardiosave intra-aortic balloon pump (iabp) balloon had broken.No patient harm reported.
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Search Alerts/Recalls
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