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
Display or Visual Feedback Problem (1184); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp and could not duplicated the reported issue.The fse reported that the issue could be due to the humidity/ moisture.The fse suggested to user to maintain the humidity and test the machine on daily basis.The unit passed all pneumatic and functional tests are working properly.The unit was returned to the customer and cleared for clinical use.
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Event Description
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It was reported that during power up, the cs100 intra-aortic balloon pump (iabp) would not switch on.When the iabp unit was switched "on", the display would flicker and the iabp unit would shut down.There was no patient involvement and no adverse event was reported.
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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 & 67) the overall 24 month product complaint trend data for the period oct 2019 through sep 2021 was reviewed.There were no triggers identified for the review period.A cr/capa/scar/ncmr review was conducted for the two year period oct 2019 through sep 2021.There were capa requests identified for the reported failure mode ¿display - blinking, discolored, static, line(s)¿ and product ¿cs100,¿ which were addressed under the capa requests and no escalation to capa is required.
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Event Description
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N/a.
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Search Alerts/Recalls
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