Model Number N/A |
Device Problem
Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/06/2020 |
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) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse inspected the iabp and found fault code #78, 112, 116 in service logs.It indicates that connection was lost between the display and console during the event.Salt deposit was also found in the coiled cable connection part of the console.Coiled cable and coiled cord to backplane cable were 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 intra-hospital transport while on a patient, the display on the cardiosave intra-aortic balloon pump (iabp) went blank and an alarm sounded.The iabp was changed for another.There was no harm or injury to the patient and no adverse event was reported.
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Event Description
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It was reported that during intra-hospital transport while on a patient, the display on the cardiosave intra-aortic balloon pump (iabp) went blank and an alarm sounded.The iabp was changed for another.There was no harm or injury to the patient and no adverse event was reported.
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Search Alerts/Recalls
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