Catalog Number FG540000 |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
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Event Description
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It was reported that a patient underwent a procedure with a carto® 3 system where a map shift occurred.It was reported that about halfway thru the case everything seemed to have shifted up about 3 cm.There was no patient movement.The patches were checked and seemed to be fine.It was also reported that all signals were in completely different locations.No errors were displayed.They remapped and noted everything was in a completely different spot.No patient consequence was reported.The ecg signal issue is not reportable, however, the map shift issue for which the carto did not display any immediate error or warning message, such map shift is a reportable malfunction.
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Manufacturer Narrative
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It was reported that about halfway thru the case everything seemed to have shifted up about 3 cm.There was no patient movement.The patches were checked and seemed to be fine.It was also reported that all signals were in completely different locations.No errors were displayed.They remapped and noted everything was in a completely different spot.No patient consequence was reported.Product evaluation: the biosense webster inc.(bwi) field service engineer (fse) spoke with a bwi representative and was informed that repair has been declined.The issue was called in for documentation purposes only and system is ready for use.Dhr review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's ref # (b)(4).
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Search Alerts/Recalls
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