Model Number 0998-00-0800-83 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
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 iabp would autofill fail the first time the start button was pressed then it would fill and pump anytime after the first time which indicated a sticky valve.The valve was on the helium reservoir assembly which was replaced.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.
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Event Description
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It was reported that during a software upgrade, the cardiosave intra-aortic balloon pump (iabp) pim module valve was sticking.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Analysis of production: (3331/213) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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