Model Number 0998-00-0800-32 |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that while demonstrating to customer, the cardiosave intra-aortic balloon pump (iabp) when removed one battery from slot 1 position while pumping was going , unit was turned off where problem is suspected with power management board which will be arranged soon.There was no patient involvement.
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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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Manufacturer Narrative
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Updated fields - e1(site country, event site postal code - (b)(6)).A getinge field service engineer evaluated unit and observed while demonstrating to customer as when we removed one battery from slot 1 position while pumping was going , unit was turned off where problem is suspected with power management board which will be arranged soon.Replaced power management board.
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Event Description
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N/a.
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Search Alerts/Recalls
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