Catalog Number 0998-00-0800-XX |
Device Problem
No Display/Image (1183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2017 |
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, however, no further details have been provided.If any additional information is provided in the future a supplemental report will be provided.
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Event Description
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The customer reported that the cardiosave intra-aortic balloon pump's (iabp) display monitor went blank when they removed the iabp from the cart in an attempt to transport a patient by air ambulance.The customer attempted to restart the iabp and it restarted normally.There was no adverse event as a result of the alleged malfunction.
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Manufacturer Narrative
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The getinge company representative reported that the fse performed running test and was able to duplicate the reported malfunction.The fse confirmed that the display failure of the monitor due to coil code.The fse replaced cable, coil cord, mounting plate, strain relief, fork, strain relief.The iabp unit was released for clinical use.
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Event Description
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The customer reported that the cardiosave intra-aortic balloon pump's (iabp) display monitor went blank when they removed the iabp from the cart in an attempt to transport a patient by air ambulance.The customer attempted to restart the iabp and it restarted normally.There was no adverse event as a result of the alleged malfunction.
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Search Alerts/Recalls
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