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

Model Number M-5830-01

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the signal interference (noise) observed on all ecg on both carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient heart rhythm.The case was completed by reconnecting a cable without any patient consequence.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an atrial fibrillation (afib) procedure, the signal interference (noise) observed on all ecg on both carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient heart rhythm.The case was completed by reconnecting a cable without any patient consequence.It was noticed that the cable was unstable and by replacing the cable (ecg out connection unit), there was no further 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 RMT 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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4293812
• MDR Text Key: 5268614
• Report Number: 3008203003-2014-00079
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090017
• 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
• Report Date: 11/13/2014

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-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1