MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS ZEEGO; INTERVENTIONAL, FLUOROSCOPIC, XRAY

Model Number 10280959

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

During the investigation, it was determined that the outlet fittings at the coolant reservoir were damaged.A corrective action was implemented to remedy affected systems.This action was reported to the fda under report 2240869-02/18/16-0005-c/ z-1283-2016 & z-1284-2016.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while using the artis zeego system.The customer reported that x-ray was blocked during a tavi case, however, the procedure was safety completed.A system check found the fd cooling reservoir was damaged.We are unaware of any impact to the state of health of the patient involved.

• Brand Name: AXIOM ARTIS ZEEGO
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC, XRAY
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5793574
• MDR Text Key: 49511015
• Report Number: 2240869-2016-02591
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/04/2016

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: No Information
• Device Model Number: 10280959
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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