MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE BIPLANE; SYSTEM, XRAY, ANGIO

Model Number 10094141

Device Problems Failure to Power Up (1476); Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

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

Event Date 06/12/2016

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.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During a patient procedure the ias a computer would not boot.A mobile c-arm was brought into the exam room to continue treatment.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 problem was identified as an error of the ias (image acquisition system) due to a power outage.In the event of an ias error, the system remains operational in regards to the procedure and fluoro and acquisition are still possible without limitation in "bypass mode".The problem itself does not represent a total loss of functionality as there is remaining imaging functionality at any time.The affected ias was exchanged and the system was returned to clinical use.The manufacturer is not considering further actions resulting from this individual event.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, ANGIO
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 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: 5920521
• MDR Text Key: 54413251
• Report Number: 2240869-2016-45261
• 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: 08/05/2016

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: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2017
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/08/2017
• 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