Model Number 0998-00-3023-55 |
Device Problems
Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the issue.The compressor assembly was 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.
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Event Description
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It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had an electrical test fail code # 50.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had an electrical test fail code # 50.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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The full name of the event site in block e1 was shortened due to field character limit; the full name is (b)(6) hospital.
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Search Alerts/Recalls
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