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

Catalog Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and the workstation was extremely hot.It was reported by the caller that when booting up the carto 3 system, they did not get any display.They changed out the power source and reseated the video cables and rebooted the system without resolution.Changing out the power source also did not resolve the issue.After the 3rd reboot it was noted that the workstation was extremely hot.There were no visible flames, no smoke and no part of the equipment was melting or carbonized.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and the workstation was extremely hot.It was reported by the caller that when booting up the carto 3 system, they did not get any display.They changed out the power source and reseated the video cables and rebooted the system without resolution.Changing out the power source also did not resolve the issue.After the 3rd reboot it was noted that the workstation was extremely hot.There were no visible flames, no smoke and no part of the equipment was melting or carbonized.Device evaluation details: it was confirmed by the biosense webster inc field service engineer (fse) that after inspection, that the work station was located in a space without the needed ventilation.According to the carto 3 system installation guide, the workstation needs to be in a well-ventilated area with ventilation and not blocked at the back.The environmental conditions need to be between 10 ¿ 30 celsius for operating and (-10) ¿ 50 celsius for storage.The issue is related to user error.Fse had informed the customer they must improve ventilation to the systems as the installation manual instructs.The hospital biomed confirmed they are working on adding fans to the computer racks.The system is ready for use.The history of customer complaints reported during the last year and associated with carto 3 system # (b)(6) was reviewed.No similar additional complaints were found.A manufacturing record evaluation was performed for system (b)(6), and no internal action related to the reported complaint condition were identified.Note: field h6.Component code was populated with code ¿part/component/sub-assembly term not applicable (g07001)¿ as the issue considered to be a related user error for hardware set up.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19009622
• MDR Text Key: 338988151
• Report Number: 2029046-2024-01078
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2024

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: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/31/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1