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

Model Number M-4800-01

Device Problem Electro-Static Discharge (2149)

Patient Problem Electric Shock (2554)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, it was reported that when the location pad (lp) cable was moved from this carto® 3 system, that the bwi representative felt an electrical shock in his hand from lp cable.The patient interface unit (piu) was shut down to be precautious prior to moving the lp.The procedure was completed successfully with no patient consequences.Due to the available information, this complaint became reportable as it may be a potential risk to the physician, patient or any person manipulating the equipment.

Manufacturer Narrative

The equipment investigation is still in progress.(b)(4).

Manufacturer Narrative

Please refer to (evaluation summary) for investigation results.Manufacturer's reference # (b)(4).During an atrial fibrilation procedure, it was reported that when the location pad (lp) cable was moved from this carto® 3 system, that the bwi representative felt an electrical shock in his hand from lp cable.The patient interface unit (piu) was shut down to be precautious prior to moving the lp.The procedure was completed successfully with no patient consequences.The patient interface unit (piu) was replaced with a new location pad (lp), an lp extension cable and magtx card.The system was sent to the device manufacturer (htc) for investigation and no failure was found.An additional oem manufacturer action (dhr review or investigation) was performed.The dhr associated with carto 3 #13038 was reviewed and there were not any discrepancies noted.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: 3631669
• MDR Text Key: 17839304
• Report Number: 3008203003-2014-00012
• 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: 01/23/2014

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: 01/23/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1