DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.Electrical code 53 was displayed in the logs.Malfunction was not reproducible.Fse calibrated transducer system to factory specifications.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.A supplemental report will be submitted when additional information is provided.The full name of the event site in was shortened due to field character limit; the full name is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) displayed electrical code 53.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: a1, b4, b5, b6, b7, d11, g4, g7, h2, h6(impact codes), h10, h11.Corrected fields: g1(contact person).
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Event Description
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It was reported that before use the cs300 intra-aortic balloon pump (iabp) displayed electrical code 53.There was no patient involved and there was 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 sep 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.
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