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

Model Number 10280959

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 08/20/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Analysis of the reported event showed that the patient presented a pathology with a higher probability to death because of a rupture of the "aorta thoarcique".The placement of a stent was executed in the room using a mobile c-arm system.The system delay as well as the patient's pathology and sequence of events are all contributing factors in the patient's death.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 axiom artis zeego system resulting in an adverse event.During an emergency procedure and once the patient was positioned on the table, no system movements were possible.A system restart was attempted and was unsuccessful.A mobile c-arm x-ray system was brought into the room in order to complete the procedure.A delay in procedure occurred due to system down time and it was reported that the patient passed away.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No single root cause could be determined for this event.The patient presented pathology with a higher probability to death because of a rupture of the "aorta thoarcique".The death of the patient is due to a multifactorial sequence of elements.Additionally, the table control module was exchanged as a preventative action and no further problems have been reported.Therefore, the manufacturer is not considering further actions resulting from this event.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 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: 6864578
• MDR Text Key: 86120136
• Report Number: 3004977335-2017-94335
• 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: 08/22/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 10280959
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death