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

Model Number 10094137

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

It was reported to siemens that an artis zee ceiling system ceased operation during a clinical procedure.The system was not able to be rebooted and the procedure was unable to continue.The pt was relocated to another system and we are not aware of any adverse health consequences.

Manufacturer Narrative

The technical investigation is still ongoing.The root cause for the event has not yet been determined.A supplement report will be filed upon completion of the investigation.This incident occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware failure of the rtc (real time computer).The affected rtc was exchanged.No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the affected component.

• Brand Name: ARTIS ZEE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE ; 51 valley stream pkwy.; malvern PA 19355
• 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: 4687685
• MDR Text Key: 21326007
• Report Number: 2240869-2015-08300
• 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: User Facility,user facility
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1