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
Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.A getinge field service engineer (fse) done video call with the biomed, the fse was able to observe the battery was charging and unit did not have any battery issue while plugged in and while not plugged in.Therefor there was no issue with battery charging.Upon completion of our investigation, a supplemental report will be submitted.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) would not charge while it was plugged in.It is unknown the circumstances under which the event occurred.There was no patient involvement; thus, no adverse event was reported.
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Manufacturer Narrative
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*the investigation type in the initial report was submitted incorrectly and 'communication/interviews|4111' should have been selected.As there was no issue with the battery as observed by fse on video call, the unit was cleared for clinical use and returned to the customer.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 jun 2019 through may 2021 was reviewed.There were no triggers identified for the review period.
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Event Description
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Na.
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Search Alerts/Recalls
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