MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS ZEE BIPLANE SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Catalog Number UNKNOWN

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

Patient was under general anesthesia in ep lab.At approx 11:34am md performed a rotation angiogram and the system did not replay the angio.Multiple attempts were made to retrieve the angiograms.The decision was made by the md to call siemens technical support line.Technical support suggested rebooting the system.This did not fix the problem.Technical support stated that there was a failure to communicate between systems and the patient needed to move to another lab to continue the procedure.Patient was safely and uneventfully moved from the ep lab to cath lab at 12:50pm.The procedure was completed in cath lab without any other problems.The system was tested in the am before cases started and functioned properly.

• Brand Name: ARTIS ZEE BIPLANE SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 4127830
• MDR Text Key: 4945042
• Report Number: 4127830
• 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: 09/19/2014

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: Physician
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2014
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 15