Model Number 0998-00-0800-53 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) resolved the issue by replacing the fiber optic sensor cable assembly.The fse performed functional and safety checks to meet factory specifications.A supplemental report will be submitted upon completion of our investigation.The initial reporter is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
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Event Description
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It was reported that while servicing the cardiosave intra-aortic balloon pump (iabp) unit, the getinge field service engineer (fse) found the port for the fiber optics broken.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The iabp was returned to the customer and cleared for clinical use after the repair was completed as mentioned in the initial emdr.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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N/a.
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Search Alerts/Recalls
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