DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC; 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 07/14/2021 |
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) medical center.Testing of actual/suspected device: a getinge field service engineer (fse) called the customer to discuss the issue and found that it was not a service issue.The console was not fully seated in the cart, causing the unit to run in rescue mode.In rescue mode the unit does not charge the batteries.The fse had them seat the console properly into the cart, and the unit proceeded to charge.The fse verified with the customer that the batteries had fully charged overnight.No issue and no onsite service required.A supplemental report will be submitted if this information is provided to us.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) batteries would not charge.It is unknown the circumstances under which the event occurred.However, 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 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 (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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