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Model Number N/A |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue, and the customer confirmed that the iabp had been calibrated numerous times, but would not hold calibration values.To fix the issue, the fse replaced the front end board and performed transducer calibrations and was able to obtain values within manufacturer specifications.The fse then verified that the unit was holding calibration values and performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that during preventative maintenance (pm) by the customer, the cs300 intra-aortic balloon pump (iabp) was unable to calibrate the transducers.It is unknown under which circumstances this event occurred; however, there was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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