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

Catalog Number FG540000

Device Problems Computer Software Problem (1112); Overheating of Device (1437)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system and the workstation's power cut-off and the temperature of the workstation were extremely hot before the case.The workstation was opened and the video card was extremely hot.There was no video to the carto 3 system.The biomed blew off the workstation with compressed air and let the workstation sit for 15 minutes.The medical team then turned the workstation on again without the cover and the issue persisted.T video card was not turning on and the video card was overheating.The patient was moved to another room and another carto 3 system was used to continue the procedure.No patient consequences were reported.The workstation has not been used since this procedure.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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 reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2024, bwi received additional information regarding the event.The medical team confirmed that there were no visible signs of smoke or fire.There was no melting during the overheating incident either.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

On 9-apr-2024, the product investigation was completed.It was reported that the patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system and the workstation's power cut-off and the temperature of the workstation were extremely hot before the case.The workstation was opened and the video card was extremely hot.There was no video to the carto 3 system.The biomed blew off the workstation with compressed air and let the workstation sit for 15 minutes.The medical team then turned the workstation on again without the cover and the issue persisted.T video card was not turning on and the video card was overheating.The patient was moved to another room and another carto 3 system was used to continue the procedure.No patient consequences were reported.The workstation has not been used since this procedure.Device evaluation details: a field service engineer inspected the device and confirmed that the work station was located in a space without the necessary/required 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 reported issue is related to user error.The field service engineer 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.A manufacturing record evaluation was performed for system 14676, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 18723123
• MDR Text Key: 335754337
• Report Number: 2029046-2024-00521
• Device Sequence Number: 1
• Product Code: DQK
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

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: 01/24/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 04/09/2024
• Supplement Dates FDA Received: 03/19/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2014
• 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