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

Model Number M-4800-01

Device Problem Radio Signal Problem (1511)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.The carto 3 system was losing the body surface (bs) ecg during the procedure.All channels were affected on both the carto 3 system and the cardiolab.The cable was bumped and the signal would come back and then go back out.When the ecgs were lost, all the other channels on the recording system were saturated.The physician did not have any ecg signal available to monitor the patient¿s heart rhythm.The procedure was continued without patient consequence.This event is reportable since the physician did not have any ecg signal available to monitor the patient¿s heart rhythm.

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

Evaluation summary: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.The carto 3 system was losing the body surface (bs) ecg during the procedure.All channels were affected on both the carto 3 system and the cardiolab.The cable was bumped and the signal would come back and then go back out.When the ecgs were lost, all the other channels on the recording system were saturated.The physician did not have any ecg signal available to monitor the patient¿s heart rhythm.The procedure was continued without patient consequence.Replacement of the bs ecg cable was sent to the account.The bwi field service engineer confirmed with the customer that the cable was received.The bs ecg cable and leads were replaced.The reported issue was resolved.System was ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate bs ecg cables failures in the field.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4685395
• MDR Text Key: 5694555
• Report Number: 3008203003-2015-00020
• 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: 03/19/2015

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 Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1