MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and experienced workstation issues since it stopped working and shut down during the procedure.The procedure was cancelled.Multiple attempts have been made to obtain clarification to this complaint.However, not enough information has been provided to correctly assess the case.This event is being reported because bwi is taking a conservative approach as we cannot confirm patient¿s status.

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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and experienced workstation issues since it stopped working and shut down during the procedure.The investigational analysis has been completed.Fse spoke to cas and cas stated that he misspoke when he stated that the ws crashed, it was just a lack of communication.Fse reported that replacement of the carto 3 workstation resolved the issue.Fse has returned workstation to the ts office as defective.The ws was checked in the ts depot lab.During testing found no issues, ran a diagnostic check and simulator, no problems found with memory or hard drive.Ran workstation d3rt95j for over 48 hours and rebooted unit at least 4 times.Booted up with no issues.Connected workstation to carto 3 system in depot lab and left running over night and rebooted 3 times no issues with connection.The ws was re-imaged and sent to warehouse as good and ready for use.The history of customer complaints associated with carto 3 system # 11841 was reviewed.5 out of 41 additional reported complaints may be related to the reported issue.A dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4358750
• MDR Text Key: 5174364
• Report Number: 3008203003-2014-00081
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1