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Model Number 0998-UC-0479-55 |
Device Problem
Power Problem (3010)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp.The fse began by checking the power supply and then it was cleaned to rectified the problem.Further more, the unit was left running for 3 hours and no problems were found.The fse performed all functional and safety checks performed to meet factory specifications.The iabp was handed over to the customer in good working condition and cleared for clinical use.
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Event Description
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It was reported that during routine check performed by the customer, the sys98 intra-aortic balloon pump (iabp) switching off automatically on mains and battery power.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 routine check performed by the customer, the sys98 intra-aortic balloon pump (iabp) switching off automatically on mains and battery power.There was no patient involvement reported.
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Manufacturer Narrative
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Updated data: b4,g2,g3,g6,h2,h10,h11.Corrected data: b5,b6,b7,d5,d10,h6(clinical & impact).
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, e1 (site country, event site postal code - (b)(6)).
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Search Alerts/Recalls
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