MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS Q BIPLANE; INTERVENTIONAL, FLUORSCOPIC XRAY SYSTEM

Model Number 10848282

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation and a root cause has not yet been determined.A supplement report will be filed at the close of the investigation.

Event Description

It was reported to siemens that when attempting to do an i-guide procedure on the artis q biplane system, a 3d spin was done as per normal procedure but no reconstruction was done by the workstation.Additionally, three 3d spins were done while attempting to get the i-guide to work.The patient was moved to a ct system to finish the procedure.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The problem was identified as a software error of the ias (image acquisition system).The investigation of the logs indicate that the image acquisition system of plane a (ias-a) sporadically reboots during a 3d-dyna-procedure.When this occurs the system enters bypass mode where the ias-a auto-recovers and full functionality is available within 2 minutes.The problem was resolved by implementing the new software version vd11c via update ax001/16/s, which was reported to the fda under 21 cfr 806; report 2240869-12/16/16-0036-c.This corrective action eliminates the root cause of the problem and prevents the possibility of reoccurrence.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL, FLUORSCOPIC XRAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5614423
• MDR Text Key: 44596888
• Report Number: 2240869-2016-35248
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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: No Information
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• 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