VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3

Additional Manufacturer Narrative

REVIEW OF THE PROVIDED FSR FOUND THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY A REPRESENTATIVE FROM MINDRAY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

Description of Event or Problem

DURING THE ATRIAL FIBRILLATION PROCEDURE, NOISE WAS NOTED ON THE IMAGE OF VIEWMATE Z ULTRASOUND CONSOLE RESULTING IN A DELAY. THE VIEWMATE Z SCAN ENGINE AND NON-ABBOTT ICE CATHETER (ACUNAV) HAD NO NOISE. THE LOCATION OF THE POWER SUPPLY WAS CHANGED, THE VIEWMATE CATHETER INTERFACE MODULE WAS EXCHANGED, AND AN ISOLATION TRANSFORMER WAS USED WITHOUT RESOLUTION. THIS ISSUE WAS NOTED WHEN THE VIEWMATE Z ULTRASOUND CONSOLE WAS USED AT ANOTHER LOCATION. THE ISSUE WAS PARTIALLY RESOLVED BY DECREASING THE FREQUENCY ON THE ICE SIDE FROM 6MHZ TO 5MHZ. THE GAIN WAS ALSO DECREASED, BUT THE ISSUE PERSISTED. DECREASING THE DR MADE THE NOISE WORSE. THE POWER SUPPLY WAS UNPLUGGED, AND THE NOISE THAT DISPLAYED TO THE CENTER WAS THEN REDUCED, BUT IT HAD NO EFFECT ON THE NOISE THAT APPEARED IN OBLIQUE CONCENTRIC CIRCLES. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS DELAYED ABOUT 45 MINUTES.