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

Model Number 10280959

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

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.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zeego system.During a patient procedure, no system movements were possible.The examination was aborted.We are unaware of any impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.An investigation was conducted using the available log files.The root cause was determined to be a loose contact at the uli board (user location interface).The uli board was exchanged and the error did not reoccur.As this is the first known event of this nature, the event does not exceed the threshold in regards to the defect acceptance level and would not lead to a general field corrective action.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 6063200
• MDR Text Key: 59041709
• Report Number: 2240869-2016-05052
• 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,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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: No Information
• Device Model Number: 10280959
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• 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