MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS ZEE FLOOR; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094135

Device Problems Partial Blockage (1065); Device Operates Differently Than Expected (2913)

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

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The problem was identified as a failure of the ivs (image virtualization system).In the event the ivs fails, the system remains operational in regards to the procedure and fluoro and acquisition are still possible without limitation.Data transfer to the ivs is not possible and for that reason, storage in the data base will fail and post processing is not possible.Correction for this failure has been initiated via update ax 075/15/s and was reported to the fda under 21 cfr 806; report 2240869-03/07/16-0010-c.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During a patient procedure the semi-automatic focus was blocked and did not switch over.We are unaware of any impact to the state of health of the patient involved.

• Brand Name: AXIOM ARTIS ZEE FLOOR
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6174080
• MDR Text Key: 62697673
• Report Number: 2240869-2016-35604
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/07/2016

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: 10094135
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/14/2016
• 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