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

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

Error message: tube too hot take a break.Manufacturer response for radiographic/fluoroscopic systems, artis zeego (per site reporter): yes siemens was informed of the issues the center is having with the "artis zeego" circulation pump.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty blvd.; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6680071
• MDR Text Key: 78805425
• Report Number: 6680071
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2017

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other