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

Model Number M-4800-01

Device Problems Pacing Problem (1439); Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

During a procedure, it was reported the user lost all the bs and ic ecg signals when come on pacing with the his 4 pole catheter connected to the 20 pole a port.The issue was resolved by switching to the 20 pole b port.Additional information received stated the signal loss occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardial) recordings.The signal loss occurred on both carto and ep recording systems at the same time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).During a procedure it was reported the user lost all the bs and ic ecg signals when come on pacing with the his 4 pole catheter connected to the 20 pole a port.The issue was resolved by switching to the 20 pole b port.Additional information received stated the signal loss occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardial) recordings.The signal loss occurred on both carto and ep recording systems at the same time.The field service engineer (fse) went onsite but could not verify the issue.After speaking with second fse it was decided to replace ecg card 2.Card was replaced and system was tested.System is functioning correctly and ready for use.The suspicious ecg card was sent to device manufacturer (htc).Htc rma reported: the customer complaint was not confirmed.This card passed tests at aquarium station, service jig station (ecg tests), tester level ii (ecg and ep out tests), megger test with success.Reported problem was not reproduced.The dhr associated with carto 3 # (b)(4) was reviewed and there were not any discrepancies noted related to the reported issue.The system met all specifications upon its release.An additional oem manufacturer action (dhr review) was performed.No anomalies were noted in manufacturing or service.The customer complaint was not confirmed.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3700791
• MDR Text Key: 4234024
• Report Number: 3008203003-2014-00022
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• 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: 03/06/2014

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-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1