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

Model Number M-4800-01

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Physical Property Issue (3008)

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

Event Date 02/21/2017

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 carto 3 system was burning.There was also some physical damage on the fiber optic cable from the workstation to the patient interface unit.Additional clarification was received on the event stating that during boot up, the workstation caught fire.There was some component inside the carto 3 system that had burned.The lab was evacuated.There was no patient or user adverse event.The reported issue of the component that burned has been assessed as a reportable malfunction.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a carto 3 system was burning.There was also some physical damage on the fiber optic cable from the workstation to the patient interface unit.Additional clarification was received on the event stating that during boot up, the workstation caught fire.There was some component inside the carto 3 system that had burned.The lab was evacuated.There was no patient or user adverse event.A replacement workstation was sent to the account.The defective workstation was replaced.System is operational.The damaged workstation that was suspected to be burned was sent to the device manufacturer for further investigation.Per the device manufacturer, the customer complaint was not reproduced and any evidence of fire burning or any smell of smoke was not found.However, during the investigation the workstation was found faulty.The power supply of the workstation was found faulty and replaced.It was also reported that there was some physical damage to the fiber optic cable from the workstation to the patient interface unit (piu).The defective fiber optic duplex cable was replaced by a new one that was delivered to the account.Issue resolved.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, 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: 6408326
• MDR Text Key: 70323882
• Report Number: 3008203003-2017-00016
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• 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: 02/21/2017
• 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