MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problem Fire (1245)

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

Event Date 08/26/2021

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.Initial reporter phone: (b)(6).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 when the loaner carto® 3 system was returned to the j&j (b)(4) repair center, the loaner team confirmed smoke emitted from the device after it was turned on.Fire was not reported.There was no report of adverse event to any person.

Manufacturer Narrative

It was reported that when the loaner carto® 3 system was returned to the j&j sukagawa repair center, the loaner team confirmed smoke emitted from the device after it was turned on.Fire was not reported.There was no report of adverse event to any person.Device evaluation details: the biosense field service engineer (fse) confirmed that the workstation (ws) was repaired by local dell engineer.The cause of the the smoke was the input/output (i/o) board.The i/o board was replaced.In addition, the mother board was replaced due to another problem found.The system is ready for use.The faulty i/o was discarded by dell engineer, therefore, further investigation by the manufacturer could not be performed.The history of customer complaints reported during the last year associated with carto 3 system #50015 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system, 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 ref.# pc-(b)(4).

Manufacturer Narrative

On 8-jun-2022, the manufactured date of 21-oct-2010 was provided, therefore, field h4.Device manufacture date been populated.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: SIMILAR DEVICE FG540000, 510K # K042999
• 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: 13115448
• MDR Text Key: 282955827
• Report Number: 2029046-2021-02273
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2022

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: Other
• Device Catalogue Number: FG540000J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 03/30/2022; 06/08/2022
• Supplement Dates FDA Received: 04/25/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2010
• 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