MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO.Q; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10848283

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Siemens has become aware of a malfunction with the artis zeego.Q system.It was reported that oil leaked from the robot arm.No other information is known at this time.There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The investigation showed that a small amount of greening tinted oil was visible at the (b)(6) motor area of axis 4/5/6 at the backside of the (b)(6) robot.The user as well as the service engineer reported that no system issue occurred due to this.Operation of the system was not compromised due to the visible oil.According to information from kuka there is no mechanical error.It might happen that a little bit too much lubricate/fat/oil is used during the assembly of the robot.In rare instances some of the lubricant/fat/oil becomes visible at the gear/motor at axis 3 of the robot and runs down the robot link.Such issue might only occur on kuka robots installed recently.The affected kuka robot was installed recently.The oil was visible at the kuka motor area of axis 4/5/6, thus not the axis 3 described by (b)(6).Nevertheless, after the robot arm was cleaned from the oil the issue has not recurred since.Based on the described observation no risk to the patient or the staff could be identified.The observation is due to the assembly and is not related to a technical deficiency.One cleaning stage of the affected near-axis system surface will solve the problem.

• Brand Name: ARTIS ZEEGO.Q
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6812771
• MDR Text Key: 83748042
• Report Number: 3004977335-2017-89875
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/30/2017

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: 10848283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2017
• Initial Date Manufacturer Received: 07/30/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1