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

Model Number M-4800-01

Device Problems Leak/Splash (1354); Over-Sensing (1438); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an afib - atrial fibrillation procedure, a current leakage error was displayed on the carto3 system, and the signal interference (noise) was observed on all ecg (bs + ic) channels on both carto 3 system and recording system.There was no evidence, whether the physician had at least one ecg signal available to monitor patient's heart rhythm.This type of issue is assessed as reportable event.The case was continued by passing carto 3 and the customer had all lead signals after switching to ge system body surface leads.The procedure was completed without any patient consequence.

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that during an afib - atrial fibrillation procedure, a current leakage error was displayed on the carto3 system, and the signal interference (noise) was observed on all ecg (bs + ic) channels on both carto 3 system and recording system.There was no evidence, whether the physician had at least one ecg signal available to monitor patient¿s heart rhythm.This type of issue is assessed as reportable event.The case was continued by passing carto 3 and the customer had all lead signals after switching to ge system body surface leads.The procedure was completed without any patient consequence.Biosense field service engineers were able to reproduce current leakage error upon initialization of the system.Field service engineers swapped ecg cards into different slots.Field service engineers booted up the system and the current leakage error did not appear then.Fse performed acceptance testing to confirm system was functioning normally.All tests passed and the system is ready for use.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 2066 717; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4878733
• MDR Text Key: 22576050
• Report Number: 3008203003-2015-00046
• 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: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1