MAUDE Adverse Event Report: BIOSENSE WEBSTER LTD. CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problems No Display/Image (1183); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2019

Event Type  malfunction  

Event Description

During the ablation portion of the case when dr.Went to ablate the catheter, images would disappear from the screen about 9 to 10 seconds into the ablation.Team tried to troubleshoot issue, but the issue persisted.Call placed to company for assistance.Equipment was removed from room; no harm to patient and procedure was finished without incident.3d cardio mapping lost images during procedure.Device is under contract with biosense webster.Biosense replaced major parts, testing was completed by field service engineer.No further action required by biomed.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER LTD.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 8949519
• MDR Text Key: 156110790
• Report Number: 8949519
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FG540000
• Device Catalogue Number: FG-5400-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA