DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Failure to Read Input Signal (1581)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.
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Event Description
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It was reported that during training, the cardiosave intra-aortic balloon pump (iabp) the touch lower screen in the display was not working.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Corrected fields: g1 (contact person), h6 (investigation type, investigation findings, component codes & investigation conclusions).A getinge field service engineer (fse) evaluated the iabp and confirmed the reported issue.To address the issue the fse replaced the lcd 19 inch touch 5 wire and display,upper hinge cover.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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Event Description
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N/a.
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Search Alerts/Recalls
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