MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH AXIOM ARTIS ZEE; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problem Overheating of Device (1437)

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

Event Date 09/29/2018

Event Type  Injury  

Event Description

At the point of getting ready to coil the patient, the tube on the angiography machine overheated, an alarm sounded and the machine shut down.

• Brand Name: AXIOM ARTIS ZEE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8008679
• MDR Text Key: 125107901
• Report Number: 8008679
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018,10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2018
• Date Report to Manufacturer: 10/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA