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
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).Testing of actual/suspected device: during a preventative maintenance (pm) service, the getinge field service engineer (fse) observed the unit's touchscreen failed the calibration procedure.To fix the issue, the fse replaced the touchscreen assembly, and 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 upon completion of our investigation.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra aortic balloon pump (iabp) unit failed the touchscreen calibration.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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