Model Number 0998-00-3013-68 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse noted the motor control board plate was damaged.The control board was removed from another iabp and put in this iabp as well as the expired safety disk being replaced.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.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 cs100 intra-aortic balloon pump (iabp) had an electrical test failure code #50.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A replacement motor control board was ordered and shipped to the customer.Repair is anticipated.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that during a routine check the cs100 intra-aortic balloon pump (iabp) had an electrical test failure code #50.There was no patient involvement and no adverse event was reported.
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Event Description
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Na.
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Event Description
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Na.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h10.Fse returned and replaced motor control board.Unit cleared for use.
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Search Alerts/Recalls
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