Model Number 0998-00-0800-53 |
Device Problem
Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) was unable to zero the arterial pressure.The zero pressure icon on the touchscreen was not responding.There was no patient harm.
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Manufacturer Narrative
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Due to character restrictions in block e1 event site name : (b)(6).A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Corrected data: b5 updated data.
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Event Description
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It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) was unable to zero the arterial pressure.The zero pressure icon on the touchscreen was not responding.There was no patient harm.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the unit, but was unable to duplicate the reported malfunction.There was no issue with the touchscreen.The fse was able to zero the blood pressure without fault while exercising the unit on a patient simulator and test catheter.The touchscreen test passed in service mode.The touchscreen was cleaned and recalibrated.The fse performed a complete preventive maintenance (pm) with full calibration.The unit passed all functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical use.
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Search Alerts/Recalls
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