Model Number 0998-00-0800-52 |
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 03/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) had a start up error code #6, a calibration of touchscreen failed.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp unit and advised that the display board is suspected to be the issue.A supplemental report will be submitted when additional information is provided.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), biomed.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and to fix the issue replaced the video generator board, and then everything was good with the unit.Unit was then released to the customer for clinical use.
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Search Alerts/Recalls
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