DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213).A getinge field service engineer (fse) was dispatched to evaluate this unit and found the console not fully seated in the cart.The fse reseated console in cart.Since the batteries were completely depleted, the fse replaced batteries.Device passed all functional and safety tests according to factory specifications.The iabp was returned to the customer and cleared for clinical use.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 during a routine check, the battery in the cardiosave intra-aortic balloon pump (iabp) was dead.Since the patient was not connected to the unit, there was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/213) 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: (4109/213) 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 jul 2019 through jun 2021 was reviewed.There were no triggers identified for the review period.
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