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

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

The carto 3 system malfunctioned.Despite troubleshooting, the room and system were unable to be used.It was later identified by tech support to be a magnet malfunction.The magnet is crucial for mapping and without this the system couldn't be uploaded.The part was ordered overnight, and tech support was on site for installation.Unfortunately, i don't have the device serial number.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive,; suite 200; irvine CA 92618
• MDR Report Key: 16077249
• MDR Text Key: 306419397
• Report Number: 16077249
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 28 KG
• Patient Race: White