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

Model Number 10280959

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2017

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

It was reported to siemens that a malfunction occurred while operating the axiom artis zeego system.During an interventional procedure, the robot arm was moved causing it to collide with the omnicell cabinet and crack the glass.The procedure was completed and there is no report of impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause has been determined as improper workmanship and misconfiguration of the system during installation.To keep the probability of a collision to a minimum, a collision computer continuously monitors the positions of all integrated components of the system with respect to one another and the room.Under normal circumstances the collision computer detects when configured distances are violated.In the present case the cse found that after the installation of the omnicell cabinet, the room was not reconfigured accordingly.Therefore the collision computer could not detect the reported collision.After the room configuration was corrected and the patient transfer position of the robot has been re-adjusted; a potential collision with the omnicell cabinet can now be detected by the system.No systematic error was identified in the field.Therefore no field corrective action is planned at this time.

• Brand Name: ARTIS ZEEGO
• 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: 6857360
• MDR Text Key: 85783054
• Report Number: 3004977335-2017-93011
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

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: 10280959
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 01/31/2018
• 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