DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-45 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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, the cardiosave intra-aortic balloon pump (iabp) unit was found to have black spots on the screen, when the phone was turned on and not used.
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Event Description
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It was reported that when turning on the machine, the cardiosave intra-aortic balloon pump (iabp) unit was found to have black spots on the screen, when the phone was turned on.It was not used by the patient.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was able to confirm the reported issue.To fix the issue, the fse replaced assy, display top lcd rohs.The fse completed full calibration, functional testing, and safety check to factory specification.The unit passed all tests performed and was returned to the customer in good working conditions.
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Event Description
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N/a.
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Search Alerts/Recalls
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