Model Number 0998-00-0800-53 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested, and we will report accordingly if it becomes available.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) was not reading the ekg.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device (10): a getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse was not able to find any major fault codes in the iabp¿s diagnostic error log.The fse tested the iabp with all customer¿s accessories, and functional tested without the any issues.All calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted when our investigation is completed.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was not picking up ekg.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Analysis of production: (3331) 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) 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) 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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Event Description
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N/a.
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Search Alerts/Recalls
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