Model Number 0998-00-0800-53 |
Device Problems
Signal Artifact/Noise (1036); Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit, but was unable to reproduce the reported issue.The fse calibrated the 30 psi transducer, as well as performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.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 use, the cardiosave intra-aortic balloon pump (iabp) did not zero or give a waveform.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Initial reporter and phone : (b)(6).A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the display assy along with labels and calibrated the psi transducer and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released for cleared for clinical service.
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Search Alerts/Recalls
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