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
No Display/Image (1183)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to reproduce the issue.The fse replaced the touchscreen and coiled cable.The 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.
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Event Description
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It was reported that prior to use on a patient, the touchscreen of the cardiosave intra-aortic balloon pump (iabp) was not working.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that prior to use on a patient, the touchscreen of the cardiosave intra-aortic balloon pump (iabp) was not working.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, d4(version or model #), g3, g6, h2, h6, h10.
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Search Alerts/Recalls
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