Model Number M-4800-01 |
Device Problems
Radio Signal Problem (1511); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2016 |
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.It was reported that there was pacing indicated on the ablation channel during radio frequency energy delivery with use of the carto 3 system during the procedure.There were no patient consequences.Pacing and ablating should not be allowed simultaneously from the same channel on the carto 3 system.This event was assessed as a reportable malfunction as there is a risk of disorganization of the electrical signal.This could mislead the physician.Therefore, the potential that this issue could cause or contribute to a death, serious injury, or other significant adverse event was possible.
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Manufacturer Narrative
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(b)(4).It was reported that a patient underwent a procedure with a carto 3 system.It was reported that there was pacing indicated on the ablation channel during radio frequency energy delivery with use of the carto 3 system during the procedure.There were no patient consequences.It was reported that the ecg card was replaced.The system was tested after card replacement.Issue resolved and system is operational.The faulty ecg card was sent to the device manufacturer for investigation.Per the device manufacturer, the customer complaint was confirmed.One of the opto-couplers was found damaged and it caused the issue.The defective element was replaced and the card returned to correct functionality.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate opto switches and tvs failures.
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Search Alerts/Recalls
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