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

Catalog Number 11491

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

Patient scheduled for atrial fibrablation ablation with carto.Pt was intubated, under general anesthesia, and trans septal puncture completed.When time for ablating, multiple alarms from system.Unable to complete procedure.Company rep here, contacted field engineering.Arrangements made for engineering to check machine.

• Brand Name: CARTO MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 8495016
• MDR Text Key: 141329089
• Report Number: 8495016
• 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: 04/05/2019,02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 11491
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 82