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

Catalog Number FG540000C

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent a procedure with a carto® 3 system and it was reported that the connector of the power cable of the display exploded.It was confirmed that the display was not functioning.There was no patient consequence reported.The reported issue of the connector of the power cable of the display exploded has been assessed as a reportable event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on september 16, 2019 and it was reported that the power cord socket on the back of the monitor burned out producing a small spark and some smoke.The monitor went black and became nonfunctional.The procedure was completed using a different monitor.There was no patient consequence reported.The biosense webster, inc.Representative stated that the event was probably caused by the unstable hospital voltage, because at the same time, there were three other displays including other company devices that had the same problem.Additional information was also received on september 16, 2019, providing the manufacture date.Device manufacture date has been populated.Manufacturer's reference # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a carto® 3 system and it was reported that the connector of the power cable of the display exploded.It was confirmed that the display was not functioning.There was no patient consequence reported.Additional information was received on september 16, 2019 and it was reported that the power cord socket on the back of the monitor burned out producing a small spark and some smoke.The monitor went black and became nonfunctional.The procedure was completed using a different monitor.There was no patient consequence reported.The biosense webster, inc.Representative stated that the event was probably caused by the unstable hospital voltage, because at the same time, there were three other displays including other company devices that had the same problem.The biosense webster, inc.Field service engineer (fse) confirmed that the issue was resolved by replacing the faulty monitor with a new one.It was confirmed that the system is performing as intended and is ready for use.Mre review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's reference # (b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9050394
• MDR Text Key: 158599222
• Report Number: 2029046-2019-03634
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 10/16/2019
• Supplement Dates FDA Received: 10/18/2019; 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1