RHYTHMIA HDXTM MAPPING SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE COMMUNICATION BETWEEN THE RHYTHMIA SCREEN WAS FROZEN DURING MAPPING. THE COMMUNICATION BETWEEN THE SIS AND THE WS WAS INTERRUPTED. RESTARTED THE SIS AND WS SEVERAL TIMES, REPLACED THE FO THREE TIMES, HOWEVER, THE COMMUNICATION BETWEEN THE SIS AND WS WAS NOT ACHIEVED. ISSUE WAS NOT ABLE TO BE RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED BUT PHYSICIAN MANAGED TO FINISH PROPERLY THE PROCEDURE. USING ANOTHER CPU TO RESOLVE THE ISSUE

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. INITIAL REPORTER PHONE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE COMMUNICATION BETWEEN THE RHYTHMIA SCREEN WAS FROZEN DURING MAPPING. THE COMMUNICATION BETWEEN THE SIS AND THE WS WAS INTERRUPTED. RESTARTED THE SIS AND WS SEVERAL TIMES, REPLACED THE FO THREE TIMES, HOWEVER, THE COMMUNICATION BETWEEN THE SIS AND WS WAS NOT ACHIEVED. ISSUE WAS NOT ABLE TO BE RESOLVED. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT AND HAD TO BE CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.