MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC ARTIS ZEEGO; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10280959

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Upon arrival to the or, the tech noticed a beeping noise from the zeego.The machine was restarted and the manufacturer representative was notified.A test x-ray was performed as part of the sop prior to arrival of the patient and the device worked correctly.The surgeon arrived and asked for a 360 scan before bringing the patient back to the room.The device would not function and there was an error message that the device overheated.The surgeon opted to cancel the case because of the degree of difficulty as the machine was repaired, which required a new cooler.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 810 innovation drive; knoxville, TN 37932
• MDR Report Key: 4293225
• MDR Text Key: 18732765
• Report Number: 4293225
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/31/2014

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: Invalid Data
• Device Model Number: 10280959
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1