MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS Q CEILING; INTERVENTIONAL, FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848281

Device Problem Device Emits Odor (1425)

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

Event Date 02/10/2016

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

A hospital technician reported an electronic burning smell from the artis q system while a patient was on the table.A siemens service engineer was onsite at the customer site at the time of the event.The engineer immediately evaluated the system, however, the smell had dissipated.Upon system reboot, the system showed a fire from t1.We are not aware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined as a short circuit of the anode drive and x-ray tube.Inspection of the x-ray tube showed a high current from the x-ray tube assembly into the x-ray generator.Inspection of the generator showed that the voltage dependent resistors on the secondary side of the transformer t1 became active for too long time a period of time causing them to become too hot and subsequently fail.Exchange of the x-ray tube and x-ray generator resolved the issue.Additionally, a field update is planned to correct systems affected starting q4/2017.

• Brand Name: ARTIS Q CEILING
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS, BUS. 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: 5510166
• MDR Text Key: 40961435
• Report Number: 2240869-2016-33324
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

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: Health Professional
• Device Model Number: 10848281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• 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