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

Model Number 10094135

Device Problem Image Display Error/Artifact (1304)

Patient Problem Reaction (2414)

Event Date 06/11/2018

Event Type  malfunction  

Event Description

Procedure: right and left heart cath.And possible coronary intervention.Imaging from siemens artis x-ray inadequate.Patient unable to tolerate additional contrast media; transferred to another facility for continued imaging and possible coronary intervention.Approximate age of device: new on (b)(6) 2009; system is 9 years old.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: SYSTEM, X-RAY ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA INC.
• MDR Report Key: 7605317
• MDR Text Key: 111431744
• Report Number: MW5077885
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other