MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS DBC; INTERVENTIONAL, FLUOROSCOPIC, X-RAY

Model Number 07728392

Device Problem Partial Blockage (1065)

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

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.(b)(6).

Event Description

It was reported to siemens that the axiom artis dbc system malfunctioned during a procedure.During a patient examination, the x-ray plane a was not possible and was blocked by angiomatic.The customer aborted the examination and the patient was safely transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed a thorough investigation fo the reported event.It was determined that the event does not represent a total loss of functionality of the system.On the biplane system, plane a was failing, however, plane b was still available and fully operational.No further actions are taken from this event and its investigation result.There is no negative awareness in regards to the quality and performance of the affected component.The failure rate is within the specified normal range and is subject to continuous post market surveillance activities.

• Brand Name: AXIOM ARTIS DBC
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC, X-RAY
• 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: 5779839
• MDR Text Key: 49767898
• Report Number: 2240869-2016-03528
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

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: 07728392
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2006
• 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