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

Model Number 10094135

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2016

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 on the artis zee floor system.During examination, the "collision control" deactivated.It was reported the potentiometer and encoder were not synchronized and movements were very slow.The examination was aborted.We are unaware 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 to be improper workmanship during installation of the potentiometer.To ensure stable and error-free position readout of moveable parts, the readout is performed redundantly with a potentiometer and encoder.In the event of a deviation between these two values, the position readout cannot be used and the system switches to an operation mode with limited speed.A message "reducedstand/table speed" is shown on the display.After exchange of the potentiometer and fixing the stud screws the system functions as specified.

• Brand Name: ARTIS ZEE FLOOR
• 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: 5779530
• MDR Text Key: 49786561
• Report Number: 2240869-2016-03428
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• 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: 06/13/2016

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: 10094135
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• 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