MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number VD11C

Device Problem Poor Quality Image (1408)

Patient Problem Radiation Overdose (1510)

Event Date 02/15/2019

Event Type  malfunction  

Event Description

Diagnostic patient in ipp 8.While using a siemens artis q fluoroscopy machine to acquire the diagnostic images, the attending in the room remarked that he could not visualize the wire adequately enough.Multiple attempts at adjusting contrast of imaging failed to make the wire readily visible without effort.Requiring unnecessary radiation dosage.The attending felt this posed a patient risk and asked us to file a report.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 2 edgewater drive; norwood MA 02062
• MDR Report Key: 8531178
• MDR Text Key: 142507497
• Report Number: 8531178
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VD11C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA