Model Number 0998-00-0800-53 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit will not power on.There was no reported injury.
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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 that before use, the cardiosave intra-aortic balloon pump (iabp) unit will not power on.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer(fse) upon arrival on site, he found device found to be partially removed from the cart.Device was reseated properly into the cart to resolve reported issues.Calibrations, functional testing, and safety testing all passed per factory specifications.Device returned to customer.
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Event Description
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N/a.
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Search Alerts/Recalls
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