Catalog 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 01/27/2021 |
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 confirmed the fiber-optic module would not display waveforms during testing but would display numeric outputs.The fse replaced the fiber-optic module and the issue was resolved.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump (iabp) had a fiber-optic module failure.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump (iabp) had a fiber-optic module failure.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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