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

Model Number 10848283

Device Problems Overheating of Device (1437); Device Inoperable (1663)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported event is still ongoing and a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a gigalix x-ray tube failed after one month of use.Additionally it was reported that the generator experienced thermal effects and the system failed completely.There was no communication of patient involvement nor an impact to the state of health of a patient or operator.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause of the short circuit was determined as a blocked anode bearing.The gigalix x-ray tube was replaced and returned for investigation.The incoming inspection showed a short-circuit to ground, which then caused the defect of the t1 transformer.Additionally, the generator was replaced and returned for root cause analysis.The visual inspection of the generator shows that the voltage dependent resistors on the secondary side of the transformer became active for a too long time.This made them become too hot and they failed.The clamps of the transformer were also involved due to this thermal effect.The transformer and the generator did not have any further functional defects.The affected x-ray tube and generator have been replaced and the system was returned to clinical use.No further issues have been reported.

• Brand Name: ARTIS ZEEGO
• 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 GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5573057
• MDR Text Key: 43167561
• Report Number: 2240869-2016-38695
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141574
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10848283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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