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

Model Number M-4800-01

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2016

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent a procedure with a carto 3 system and all body surface and intercardiac signals had noise on both the carto 3 system and the recording system.No signals were able to be seen.The only source of vital data was the pressure curve on a second system.The procedure could be completed without further issues as the noise disappeared as soon as the pacing channel on the carto 3 system was closed.There was no patient consequence.The lack of monitoring of the cardiac rhythm while devices are intracardiac was assessed as a reportable malfunction as it may lead to an undetected cardiac rhythm that can be life threatening.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a carto 3 system and all body surface and intercardiac signals had noise on both the carto 3 system and the recording system.No signals were able to be seen.The only source of vital data was the pressure curve on a second system.The procedure could be completed without further issues as the noise disappeared as soon as the pacing channel on the carto 3 system was closed.There was no patient consequence.Backplane was replaced successfully.Atp/preventative maintenance was performed successfully.System is running according to the specification and is ready for clinical use.Backplane was sent to the device manufacturer for investigation and the customer's complaint was not confirmed.Backplane card was tested and found operable.No issue was found during the backplane investigation.The device history record (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 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5665612
• MDR Text Key: 46696147
• Report Number: 3008203003-2016-00016
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• 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: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1