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

Model Number 10094141

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 11/06/2016

Event Type  Death  

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 patient required cardiopulmonary resuscitation while being examined on the artis zee biplane system.During examination, the customer reported the system was not operating properly.The patient was safely transported to an alternate system to continue the examination.It was reported that the patient expired during examination on the alternate system.The cause of death is unknown at this time.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be an ias hardware failure.Investigation showed that the system identified a network problem or ias down and the system entered bypass.Multiple x-ray state changes were shown prior to the customer initiated emergency button activation.Until the emergency button was activated no x-ray was possible.The log files show that the restart process began and multiple fluoro footswitches occurred in bypass mode until the next application shutdown, which was initiated by the customer.After that shutdown a remote service session was logged.Failure of this nature does not result in a total loss of the acquisition system as "bypass fluoro" function is still available and the system is able to recover from such a situation.A patient death did occur, however, a cause-and-effect relationship between the failure could not be determined.

• Brand Name: ARTIS ZEE BIPLANE
• 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 GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6144679
• MDR Text Key: 61431124
• Report Number: 2240869-2016-06381
• 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,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094141
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• 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
• Patient Outcome(s): Death