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

Catalog Number FG540000C

Device Problem Fire (1245)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.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.(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a fire hazard issue occurred.During the practice of using the simulator, smoke appeared on the workstation, and the workstation cannot be started normally.The machine software version provided by the repair applicant was v6, and the specific software version cannot be provided.No adverse patient consequence was reported.With the information currently available, this issue was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The hardware investigation was completed on 31-mar-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a fire hazard issue occurred.During the practice of using the simulator, smoke appeared on the workstation, and the workstation cannot be started normally.The machine software version provided by the repair applicant was v6, and the specific software version cannot be provided.No adverse patient consequence was reported.Hardware investigation details: it was confirmed that the issue was resolved by replacing the defective workstation with a new one that was delivered to the account.The system was ready for use.The replaced workstation (ws) was sent to the manufacturer for investigation.The customer complaint was confirmed.During the investigation, the workstation¿s front panel was found bent and caused the reported issue.The manufacturer confirmed that this workstation is non repairable and was scrapped directly at the manufacturer site.The history of customer complaints reported during the last year associated with carto 3 system #60034 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 60034, and no internal actions related to the reported complaint condition were identified.A manufacturing record evaluation was performed on carto 3 ws #cgc0bq2, 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: pc-(b)(4).

Manufacturer Narrative

E1.Initial reporter facility name (cont.): affiliated to (b)(6) medical college.Additional information was provided on 7-jan-2022.Clarification was received on the facility name.The facility name is (b)(6)hospital affiliated to (b)(6) medical college.Therefore, e1.Initial reporter facility name has been updated.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13041660
• MDR Text Key: 282481057
• Report Number: 2029046-2021-02230
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

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: FG540000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/07/2022; 03/31/2022
• Supplement Dates FDA Received: 02/01/2022; 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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