MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS DFC; INTERVENTIONAL, FLUOROSCOPIC XRAY SYSTEM

Model Number 07412807

Device Problem Circuit Failure (1089)

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

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens is currently conducting an investigation into the reported event and a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.This event occurred in (b)(6).

Event Description

It was reported to siemens that while using the axiom artis dfc system, a short circuit in the scm cable leads resulted in a failure of the control module.The "emergency stop" was activated.We are unaware of any impact to the state of health to the patient involved.

Manufacturer Narrative

Siemens has completed an investigation fo the reported event.No definite root cause could be identified for this event as the parts were discarded after trouble shooting and exchange.As per the description of the service engineer, there was damage of the cables at the scm (stand control module).This damage was described as not resulting from regular handling.This description is similar to earlier investigation on parts returned due to damage.Usually damage of such degree will be identified and parts change before failing.

• Brand Name: AXIOM ARTIS DFC
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC XRAY SYSTEM
• 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: 5740865
• MDR Text Key: 48730037
• Report Number: 2240869-2016-03044
• Device Sequence Number: 1
• Product Code: OWB
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 07412807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• 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