Model Number 0998-00-0800-55 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
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 has a problem turning on the screen when starting the device and opening of the folding display, the screen does not light up until the next attempt.There was no patient injury or harm reported.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) unit has a problem turning on the screen when starting the device and opening of the folding display, the screen does not light up until the next attempt.There was no patient involved.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp but was unable to reproduce the reported issue.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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