Manufacturer's ref.No: (b)(4) it was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with a carto 3 system.It was reported that the carto 3 system application restarted on its own.Software crash.No data loss was reported.The procedure was continued after restart.The history of customer complaints associated with this specific system were reviewed and it was found that the issue was not reported anymore.System is operational.It was also reported that there was a map shift.No active troubleshooting could be performed.The procedure was completed successfully.The biosense webster field service engineer completed the full system test in accordance with atp.All tests passed.System is operational.The biosense webster field service engineer followed up with biosense webster representative and confirmed that after weeks of procedures, this issue was not duplicated.System is ready for use.The device history record (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.An internal corrective action has been opened to investigate the carto 3 sw crashes.
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