Model Number 0998-00-0800-53 |
Device Problems
Circuit Failure (1089); Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2023 |
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 that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) units system statistics were erased after replacing executive processor chip.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional customer contact information - (b)(6).It was reported that during preventive maintenance done by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump(iabp) had faulty executive processor board.Fse resolved the issue by replacing the mca000000108 cardiosave rtc nvram ic replacement kit.System statistics were erased after replacing executive processor chip.Fse then performed tests and released the unit for clinical use.
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Search Alerts/Recalls
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