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Model Number N/A |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to investigate the reported issue and could not duplicate issue; however, replaced coiled cable as a preventative step.Tested during preventive maintenance of device and all functional and safety checks passed as per factory specifications.The iabp returned to customer and was cleared for clinical use.(b)(6).
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Event Description
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It was reported that during power up test the cs300 intra-aortic balloon pump (iabp) monitor has static.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 records 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 ((b)(6) 2019 through (b)(6) 2021) was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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