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
Unable to Obtain Readings (1516)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit, but was unable to reproduce the reported issue.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted when additional information is provided.(b)(6).
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Event Description
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It was reported that during use, the ap waveform disappeared from the screen of the cardiosave intra-aortic balloon pump (iabp) as the end user adjusted the reference line with the ¿ref line¿ button.It was also reported that the pump was operating normally, except without the waveform being displayed or pressure indices.Notwithstanding, the augmentation pressure was present.However, the end user further reported that the printing strip presented an ap waveform.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that during use, the arterial pressure (ap) waveform disappeared from the screen of the cardiosave intra-aortic balloon pump (iabp) as the end user adjusted the reference line with the ¿ref line¿ button.It was also reported that the pump was operating normally, except without the waveform being displayed or pressure indices.Notwithstanding, the augmentation pressure was present.However, the end user further reported that the printing strip presented an ap waveform.The end user reported that they were successfully slaving the ap from the bedside monitor.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same 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.Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported 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.
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