MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 20 POLE ECO CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number EM5050060

Device Problem Computer Operating System Problem (2898)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

We are reporting a total of 41 events with different models of electrophysiological ablation catheters by biosense webster, which occurred in the past year.In this report, we have listed 01 event out of the 41 events.The details are below: brand name: 20 pole eco cable, malfunction: error 41, system did not recognize.

• Brand Name: 20 POLE ECO CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 11272202
• MDR Text Key: 230063989
• Report Number: 11272202
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EM5050060
• Device Catalogue Number: EM5050060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1