DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-55 |
Device Problems
Device Alarm System (1012); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse found moisture on the machine and cleaned it, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) was showing technical error 50.There was no patient involvement, and no adverse event 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 jun-2019 through may-2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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