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

Model Number 10094141

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

Siemens was notified that an artis zee biplane system did not release x-ray at the beginning of a procedure.The initial investigation shows a faulty communication of the mdm "multi display manager" as the possible root cause of this event.The problem will not occur systematically, but sporadic.When the problem occurs, x-ray is blocked until a reboot is performed according to the respective description from the ifu.

Manufacturer Narrative

Siemens has initiated a corrective action for all affected customers with update instructions ax011/14/s and ax007/14/s.This action has been reported to the fda under report # 2240869-06/11/14-0021-c.This event occurred in (b)(6).

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS AG
• Manufacturer Contact: meredith adams ; 51 valley stream pkwy.; d02; malvern, PA 19355 ; 6104483237
• MDR Report Key: 4003098
• MDR Text Key: 4694507
• Report Number: 2240869-2014-03742
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/27/2014

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: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/26/2014
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1