MAUDE Adverse Event Report: SIEMENS AG ARTIS ZEE BIPLANE; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094141

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 06/24/2014

Event Type  Injury  

Event Description

A customer reported to siemens that during a case, the doctor was injecting contrast into the pt during roadmap and received an error message stating "xray aborted, try again." the pt was taken to surgery to release pressure caused by the contrast impairing the pts vision.Siemens has not been notified that the event caused a change in the state of health of the pt.

Manufacturer Narrative

At this time, siemens is conducting a complete investigation of the reported event.The investigation is ongoing and no conclusion has yet to be determined.A supplement report will be filed at the conclusion of the investigation when a root cause has been established.This report is being filed with the fda on (b)(4) 2014.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG
• Manufacturer (Section G): SIEMENS AG
• Manufacturer Contact: meredith adams ; 51 valley stream pkwy.; d02; malvern, PA 19355 ; 6104483237
• MDR Report Key: 3981443
• MDR Text Key: 4750852
• Report Number: 2240869-2014-05462
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/28/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention